Trial Outcomes & Findings for Assessment of Efficacy and Safety of Olmesartan Medoxomil in Children and Adolescent Patients With High Blood Pressure (NCT NCT00151775)
NCT ID: NCT00151775
Last Updated: 2016-06-30
Results Overview
The efficacy dose response change in trough seated systolic blood pressure (both non-weight adjusted and weight adjusted results) from baseline to the end of the dose-ranging period (Period 2). Non-weight adjusted dose was the fixed olmesartan medoxomil dose; weight adjusted dose calculated mg of olmesartan medoxomil per kg of weight at baseline.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
362 participants
Primary outcome timeframe
Day 0 to 3 weeks
Results posted on
2016-06-30
Participant Flow
Period 1 was a screening, wash-out period of approximately two weeks. All participants were included in the screening, wash-out period and during this period no intervention was administered.
Participant milestones
| Measure |
Cohort A: High Dose OM in Periods 2, 3
Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
|
Cohort A: Low Dose OM in Periods 2, 3
Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
|
Cohort A: Placebo in Period 3 (From High Dose in Period 2)
Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous high dose of olmesartan
|
Cohort A: Placebo in Period 3 (From Low Dose in Period 2)
Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous low dose of olmesartan.
|
Cohort A: Period 4 Open-label OM
All members of Cohort A (6-16 years old with a limit on the number of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4 (weeks 6-51). Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
|
Cohort B: High Dose OM in Periods 2, 3
Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
|
Cohort B: Low Dose OM in Periods 2, 3
Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
|
Cohort B: Placebo in Period 3 (From High Dose in Period 2)
Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous high dose of olmesartan.
|
Cohort B: Placebo in Period 3 (From Low Dose in Period 2)
Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous low dose of olmesartan.
|
Cohort B: Period 4 Open-label OM
All members of Cohort B (6-16 years old comprised exclusively of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4 (weeks 6-51). Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
|
Cohort C: OM in Periods 2, 3, 4
Cohort C (1-5 years old) was given olmesartan medoxomil (OM) 0.3 mg/kg in Period 2 (open-label period from day 0 to week 3) and a subgroup of Cohort C was given that dose of OM during Period 3 (double-blind, placebo-controlled period from week 3 to week 5). In Period 4 (open-label period from weeks 6-51), all of Cohort C received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
|
Cohort C: Placebo in Period 3 (From OM in Period 2)
Subgroup of Cohort C (1-5 years old) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 2 - Double-Blind Dose Response
STARTED
|
95
|
95
|
0
|
0
|
0
|
56
|
56
|
0
|
0
|
0
|
60
|
0
|
|
Period 2 - Double-Blind Dose Response
COMPLETED
|
93
|
89
|
0
|
0
|
0
|
54
|
53
|
0
|
0
|
0
|
59
|
0
|
|
Period 2 - Double-Blind Dose Response
NOT COMPLETED
|
2
|
6
|
0
|
0
|
0
|
2
|
3
|
0
|
0
|
0
|
1
|
0
|
|
Period 3: Double-blind, Withdrawal
STARTED
|
48
|
45
|
45
|
44
|
0
|
26
|
27
|
28
|
26
|
0
|
29
|
29
|
|
Period 3: Double-blind, Withdrawal
COMPLETED
|
48
|
45
|
42
|
44
|
0
|
25
|
26
|
27
|
26
|
0
|
29
|
28
|
|
Period 3: Double-blind, Withdrawal
NOT COMPLETED
|
0
|
0
|
3
|
0
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
1
|
|
Period 4: Open Label
STARTED
|
0
|
0
|
0
|
0
|
179
|
0
|
0
|
0
|
0
|
104
|
57
|
0
|
|
Period 4: Open Label
COMPLETED
|
0
|
0
|
0
|
0
|
149
|
0
|
0
|
0
|
0
|
83
|
57
|
0
|
|
Period 4: Open Label
NOT COMPLETED
|
0
|
0
|
0
|
0
|
30
|
0
|
0
|
0
|
0
|
21
|
0
|
0
|
Reasons for withdrawal
| Measure |
Cohort A: High Dose OM in Periods 2, 3
Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
|
Cohort A: Low Dose OM in Periods 2, 3
Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
|
Cohort A: Placebo in Period 3 (From High Dose in Period 2)
Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous high dose of olmesartan
|
Cohort A: Placebo in Period 3 (From Low Dose in Period 2)
Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous low dose of olmesartan.
|
Cohort A: Period 4 Open-label OM
All members of Cohort A (6-16 years old with a limit on the number of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4 (weeks 6-51). Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
|
Cohort B: High Dose OM in Periods 2, 3
Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
|
Cohort B: Low Dose OM in Periods 2, 3
Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
|
Cohort B: Placebo in Period 3 (From High Dose in Period 2)
Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous high dose of olmesartan.
|
Cohort B: Placebo in Period 3 (From Low Dose in Period 2)
Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous low dose of olmesartan.
|
Cohort B: Period 4 Open-label OM
All members of Cohort B (6-16 years old comprised exclusively of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4 (weeks 6-51). Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
|
Cohort C: OM in Periods 2, 3, 4
Cohort C (1-5 years old) was given olmesartan medoxomil (OM) 0.3 mg/kg in Period 2 (open-label period from day 0 to week 3) and a subgroup of Cohort C was given that dose of OM during Period 3 (double-blind, placebo-controlled period from week 3 to week 5). In Period 4 (open-label period from weeks 6-51), all of Cohort C received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
|
Cohort C: Placebo in Period 3 (From OM in Period 2)
Subgroup of Cohort C (1-5 years old) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5).
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 2 - Double-Blind Dose Response
Adverse Event
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 - Double-Blind Dose Response
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Period 2 - Double-Blind Dose Response
Protocol Violation
|
0
|
4
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 - Double-Blind Dose Response
Other
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 - Double-Blind Dose Response
non-compliance
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 - Double-Blind Dose Response
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 2 - Double-Blind Dose Response
The blood pressure goal was met
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 3: Double-blind, Withdrawal
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3: Double-blind, Withdrawal
Other
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Period 3: Double-blind, Withdrawal
Met blood pressure goal
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Period 3: Double-blind, Withdrawal
Adverse Event
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3: Double-blind, Withdrawal
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period 3: Double-blind, Withdrawal
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Period 4: Open Label
Increased blood pressure
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Period 4: Open Label
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
5
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Period 4: Open Label
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Period 4: Open Label
Lost to Follow-up
|
0
|
0
|
0
|
0
|
17
|
0
|
0
|
0
|
0
|
7
|
0
|
0
|
|
Period 4: Open Label
Non-compliance with protocol
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
0
|
0
|
4
|
0
|
0
|
|
Period 4: Open Label
Other
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
|
Period 4: Open Label
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
|
Period 4: Open Label
Protocol Violation
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Assessment of Efficacy and Safety of Olmesartan Medoxomil in Children and Adolescent Patients With High Blood Pressure
Baseline characteristics by cohort
| Measure |
Cohort A: High Dose OM
n=95 Participants
Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
|
Cohort A: Low Dose OM
n=95 Participants
Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
|
Cohort B: High Dose OM
n=56 Participants
Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
|
Cohort B: Low Dose OM
n=56 Participants
Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
|
Cohort C: OM (Olmesartan Medoxomil)
n=60 Participants
Cohort C (1-5 years old) was given olmesartan medoxomil (OM) 0.3 mg/kg in Period 2 (open-label period) and a subgroup of Cohort C was given that dose of OM during Period 3 (double-blind, placebo-controlled period). In Period 4 (open-label period), all of Cohort C received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
|
Total
n=362 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
12.1 years
STANDARD_DEVIATION 2.97 • n=5 Participants
|
12.3 years
STANDARD_DEVIATION 2.98 • n=7 Participants
|
12.2 years
STANDARD_DEVIATION 2.83 • n=5 Participants
|
12.8 years
STANDARD_DEVIATION 2.42 • n=4 Participants
|
3.4 years
STANDARD_DEVIATION 1.45 • n=21 Participants
|
12.3 years
STANDARD_DEVIATION 2.85 • n=10 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
149 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
213 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
Latino/Hispanic
|
42 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
117 Participants
n=10 Participants
|
|
Race/Ethnicity, Customized
non-Latino/Hispanic
|
53 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
55 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
245 Participants
n=10 Participants
|
|
Height
|
153.3 cm
STANDARD_DEVIATION 18.46 • n=5 Participants
|
155.1 cm
STANDARD_DEVIATION 19.12 • n=7 Participants
|
154.2 cm
STANDARD_DEVIATION 17.83 • n=5 Participants
|
156.1 cm
STANDARD_DEVIATION 14.21 • n=4 Participants
|
98.3 cm
STANDARD_DEVIATION 12.92 • n=21 Participants
|
154.6 cm
STANDARD_DEVIATION 17.79 • n=10 Participants
|
|
Seated Systolic blood pressure
|
129.1 mm Hg
STANDARD_DEVIATION 8.32 • n=5 Participants
|
129.5 mm Hg
STANDARD_DEVIATION 9.10 • n=7 Participants
|
130.8 mm Hg
STANDARD_DEVIATION 9.73 • n=5 Participants
|
131.7 mm Hg
STANDARD_DEVIATION 9.12 • n=4 Participants
|
115.2 mm Hg
STANDARD_DEVIATION 8.74 • n=21 Participants
|
130.0 mm Hg
STANDARD_DEVIATION 9.00 • n=10 Participants
|
|
Seated diastolic blood pressure
|
76.3 mm Hg
STANDARD_DEVIATION 8.09 • n=5 Participants
|
78.1 mm Hg
STANDARD_DEVIATION 8.17 • n=7 Participants
|
79.2 mm Hg
STANDARD_DEVIATION 7.08 • n=5 Participants
|
79.4 mm Hg
STANDARD_DEVIATION 9.05 • n=4 Participants
|
72.7 mm Hg
STANDARD_DEVIATION 8.74 • n=21 Participants
|
78.0 mm Hg
STANDARD_DEVIATION 8.18 • n=10 Participants
|
|
Weight
|
68.0 kg
STANDARD_DEVIATION 34.22 • n=5 Participants
|
78.9 kg
STANDARD_DEVIATION 41.85 • n=7 Participants
|
66.2 kg
STANDARD_DEVIATION 32.39 • n=5 Participants
|
68.1 kg
STANDARD_DEVIATION 34.36 • n=4 Participants
|
16.9 kg
STANDARD_DEVIATION 6.61 • n=21 Participants
|
71.1 kg
STANDARD_DEVIATION 36.72 • n=10 Participants
|
PRIMARY outcome
Timeframe: Day 0 to 3 weeksPopulation: The number of participants includes all randomized to Cohort A, Cohort B and a combination of the two cohorts. The Last Observation Carried Forward method was used in the linear regression analysis for the change in the seated systolic blood pressure from baseline to the end of three weeks.
The efficacy dose response change in trough seated systolic blood pressure (both non-weight adjusted and weight adjusted results) from baseline to the end of the dose-ranging period (Period 2). Non-weight adjusted dose was the fixed olmesartan medoxomil dose; weight adjusted dose calculated mg of olmesartan medoxomil per kg of weight at baseline.
Outcome measures
| Measure |
Cohort A
n=190 Participants
Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.
|
Cohort B
n=112 Participants
Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0 mg), depending on weight, administered once daily.
|
Cohorts A + B
n=302 Participants
Cohort A + B participants were 6-16 years old. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.
|
Cohort B: High Dose OM
Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
|
Cohorts A + B: Low Dose OM
Subgroup from Cohorts A + B (6-16 years old) who received the low dose of olmesartan medoxomil suspension (OM 2.5 mg or 5.0 mg depending on weight), administered once daily in Period 2. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants.
|
Cohorts A + B: High Dose OM
Subgroup from Cohorts A + B (6-16 years old) who received the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg depending on weight), administered once daily in Period 2. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants.
|
|---|---|---|---|---|---|---|
|
Least Squares Mean Change From Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 Weeks)
Non-weight adjusted dosage
|
-0.69 mm Hg
Standard Error 0.202
|
-0.85 mm Hg
Standard Error 0.282
|
-0.75 mm Hg
Standard Error 0.165
|
—
|
—
|
—
|
|
Least Squares Mean Change From Baseline in Seated Systolic Blood Pressure to the End of Period 2 (3 Weeks)
Weight adjusted dosage
|
-8.97 mm Hg
Standard Error 2.054
|
-7.17 mm Hg
Standard Error 3.190
|
-8.36 mm Hg
Standard Error 1.750
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 (baseline) to 3 weeksPopulation: The Intent-to-Treat (ITT) population for Period II of the study was defined as subjects who took at least one dose of study medication and had study baseline and at least one seated systolic, or diastolic blood pressure measurement after taking study medication. The Last Observation carried forward was used
Mean change from baseline to the end of the dose ranging period in systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.
Outcome measures
| Measure |
Cohort A
n=94 Participants
Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.
|
Cohort B
n=94 Participants
Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0 mg), depending on weight, administered once daily.
|
Cohorts A + B
n=56 Participants
Cohort A + B participants were 6-16 years old. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.
|
Cohort B: High Dose OM
n=56 Participants
Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
|
Cohorts A + B: Low Dose OM
n=150 Participants
Subgroup from Cohorts A + B (6-16 years old) who received the low dose of olmesartan medoxomil suspension (OM 2.5 mg or 5.0 mg depending on weight), administered once daily in Period 2. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants.
|
Cohorts A + B: High Dose OM
n=150 Participants
Subgroup from Cohorts A + B (6-16 years old) who received the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg depending on weight), administered once daily in Period 2. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 2 (3 Weeks)
Change in Systolic Blood Pressure
|
-7.76 mm Hg
Standard Deviation 9.180
|
-12.58 mm Hg
Standard Deviation 10.157
|
-4.73 mm Hg
Standard Deviation 11.483
|
-10.68 mm Hg
Standard Deviation 9.259
|
-6.63 mm Hg
Standard Deviation 10.170
|
-11.87 mm Hg
Standard Deviation 9.843
|
|
Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 2 (3 Weeks)
Change in Diastolic Blood Pressure
|
-5.52 mm Hg
Standard Deviation 8.058
|
-9.50 mm Hg
Standard Deviation 9.757
|
-3.49 mm Hg
Standard Deviation 8.844
|
-7.58 mm Hg
Standard Deviation 8.172
|
-4.76 mm Hg
Standard Deviation 8.389
|
-8.78 mm Hg
Standard Deviation 9.216
|
SECONDARY outcome
Timeframe: Week 3 (period 3 baseline) to week 5 (end of Period 3)Population: Intent to treat population defined as subjects who finished Period 2, had the end of Period 2 seated systolic or diastolic blood pressure measurement, took the Period 3 study medication for at least one week, and had the end of Period 3 seated systolic or diastolic blood pressure measurement.
Mean change from period 3 baseline (completion of the dose adjustment period and prior to starting the treatment of period 3) to the end of period 3 (double-blind placebo-controlled period) in seated systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.
Outcome measures
| Measure |
Cohort A
n=93 Participants
Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.
|
Cohort B
n=89 Participants
Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0 mg), depending on weight, administered once daily.
|
Cohorts A + B
n=53 Participants
Cohort A + B participants were 6-16 years old. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.
|
Cohort B: High Dose OM
n=54 Participants
Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
|
Cohorts A + B: Low Dose OM
n=146 Participants
Subgroup from Cohorts A + B (6-16 years old) who received the low dose of olmesartan medoxomil suspension (OM 2.5 mg or 5.0 mg depending on weight), administered once daily in Period 2. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants.
|
Cohorts A + B: High Dose OM
n=143 Participants
Subgroup from Cohorts A + B (6-16 years old) who received the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg depending on weight), administered once daily in Period 2. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants.
|
|---|---|---|---|---|---|---|
|
Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3
Change in Systolic Blood Pressure
|
0.43 mm Hg
Standard Deviation 9.46
|
4.93 mm Hg
Standard Deviation 9.62
|
1.37 mm Hg
Standard Deviation 9.50
|
3.79 mm Hg
Standard Deviation 10.00
|
0.77 mm Hg
Standard Deviation 9.451
|
4.50 mm Hg
Standard Deviation 9.745
|
|
Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3
Change in Diastolic Blood Pressure
|
0.24 mm Hg
Standard Deviation 8.12
|
4.43 mm Hg
Standard Deviation 10.15
|
1.94 mm Hg
Standard Deviation 7.10
|
3.25 mm Hg
Standard Deviation 8.74
|
0.85 mm Hg
Standard Deviation 7.790
|
3.99 mm Hg
Standard Deviation 9.627
|
SECONDARY outcome
Timeframe: Week 3 (period 3 baseline) to week 5 (end of Period 3)Population: Intent to treat population defined as subjects who finished Period 2, had the end of Period 2 seated systolic or diastolic blood pressure measurement, took the Period 3 study medication for at least one week, and had the end of Period 3 seated systolic or diastolic blood pressure measurement.
Mean change from period 3 baseline (completion of the dose adjustment period and prior to starting the treatment of period 3) to the end of period 3 (double-blind placebo-controlled period) in seated systolic and diastolic blood pressure readings for Cohort C.
Outcome measures
| Measure |
Cohort A
n=29 Participants
Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.
|
Cohort B
n=29 Participants
Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0 mg), depending on weight, administered once daily.
|
Cohorts A + B
Cohort A + B participants were 6-16 years old. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.
|
Cohort B: High Dose OM
Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
|
Cohorts A + B: Low Dose OM
Subgroup from Cohorts A + B (6-16 years old) who received the low dose of olmesartan medoxomil suspension (OM 2.5 mg or 5.0 mg depending on weight), administered once daily in Period 2. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants.
|
Cohorts A + B: High Dose OM
Subgroup from Cohorts A + B (6-16 years old) who received the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg depending on weight), administered once daily in Period 2. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants.
|
|---|---|---|---|---|---|---|
|
Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3
Seated Systolic Blood Pressure
|
1.36 mm Hg
Standard Deviation 8.994
|
4.95 mm Hg
Standard Deviation 8.568
|
—
|
—
|
—
|
—
|
|
Mean Change From Period 3 Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 3
Seated Diastolic Blood Pressure
|
0.31 mm Hg
Standard Deviation 8.556
|
3.77 mm Hg
Standard Deviation 7.203
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 to week 51 (end of study)Population: Intent to treat population includes participants with at least one visit in Period 4.
Mean change from baseline to the end of the open label Period 4 in seated systolic and diastolic blood pressure readings for Cohort A, Cohort B and Cohorts A+B combined.
Outcome measures
| Measure |
Cohort A
n=178 Participants
Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.
|
Cohort B
n=103 Participants
Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0 mg), depending on weight, administered once daily.
|
Cohorts A + B
n=281 Participants
Cohort A + B participants were 6-16 years old. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.
|
Cohort B: High Dose OM
Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
|
Cohorts A + B: Low Dose OM
Subgroup from Cohorts A + B (6-16 years old) who received the low dose of olmesartan medoxomil suspension (OM 2.5 mg or 5.0 mg depending on weight), administered once daily in Period 2. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants.
|
Cohorts A + B: High Dose OM
Subgroup from Cohorts A + B (6-16 years old) who received the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg depending on weight), administered once daily in Period 2. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)
Change in Systolic Blood Pressure
|
-10.8 mm Hg
Standard Deviation 9.75
|
-7.7 mm Hg
Standard Deviation 12.71
|
-9.7 mm Hg
Standard Deviation 11.01
|
—
|
—
|
—
|
|
Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)
Change in Diastolic Blood Pressure
|
-7.4 mm Hg
Standard Deviation 9.31
|
-5.1 mm Hg
Standard Deviation 9.45
|
-6.6 mm Hg
Standard Deviation 9.41
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 0 to week 51 week (end of study)Population: 57=the number of participants who received medication in Period 4
Mean change from baseline to the end of the open label Period 4 in seated systolic and diastolic blood pressure readings for Cohort C.
Outcome measures
| Measure |
Cohort A
n=57 Participants
Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.
|
Cohort B
Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0 mg), depending on weight, administered once daily.
|
Cohorts A + B
Cohort A + B participants were 6-16 years old. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.
|
Cohort B: High Dose OM
Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
|
Cohorts A + B: Low Dose OM
Subgroup from Cohorts A + B (6-16 years old) who received the low dose of olmesartan medoxomil suspension (OM 2.5 mg or 5.0 mg depending on weight), administered once daily in Period 2. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants.
|
Cohorts A + B: High Dose OM
Subgroup from Cohorts A + B (6-16 years old) who received the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg depending on weight), administered once daily in Period 2. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants.
|
|---|---|---|---|---|---|---|
|
Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)
Change in Systolic Blood Pressure
|
-15.7 mm Hg
Standard Deviation 9.83
|
—
|
—
|
—
|
—
|
—
|
|
Mean Change From Baseline in Seated Systolic and Diastolic Blood Pressure Measurements to the End of Period 4 (End of Study)
Change in Diastolic Blood Pressure
|
-13.3 mm Hg
Standard Deviation 11.18
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Cohort A: Period 2 High Dose OM
Serious events: 2 serious events
Other events: 47 other events
Deaths: 0 deaths
Cohort A: Period 2 Low Dose OM
Serious events: 1 serious events
Other events: 46 other events
Deaths: 0 deaths
Cohort A: Period 3 OM High Dose Continued
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Cohort A: Period 3 Placebo From High Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort A: Period 3 OM Low Dose Continued
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort A: Period 3 Placebo From Low Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Cohort A: Period 4 Open-label OM
Serious events: 20 serious events
Other events: 128 other events
Deaths: 0 deaths
Cohort B: Period 2 High Dose OM
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Cohort B: Period 2 Low Dose OM
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort B: Period 3 OM High Dose Continued
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort B: Period 3 Placebo From High Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort B: Period 3 OM Low Dose Continued
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort B: Period 3 Placebo From Low Dose
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort B: Period 4 Open-label OM
Serious events: 7 serious events
Other events: 56 other events
Deaths: 0 deaths
Cohort C: Period 2 Open-label OM
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort C: Period 3 OM Dose Continued
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort C: Period 3 Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Cohort C: Period 4 Open-label OM
Serious events: 6 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort A: Period 2 High Dose OM
n=95 participants at risk
For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 20 mg or 40 mg, depending on weight.
|
Cohort A: Period 2 Low Dose OM
n=95 participants at risk
For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 2.5 mg or 5 mg, depending on weight.
|
Cohort A: Period 3 OM High Dose Continued
n=48 participants at risk
The 20 mg or 40 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
|
Cohort A: Period 3 Placebo From High Dose
n=45 participants at risk
Placebo was given instead of the previous high dose of olmesartan
|
Cohort A: Period 3 OM Low Dose Continued
n=45 participants at risk
The 2.5 mg or 5 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
|
Cohort A: Period 3 Placebo From Low Dose
n=44 participants at risk
Placebo was given instead of the previous low dose of olmesartan
|
Cohort A: Period 4 Open-label OM
n=178 participants at risk；n=179 participants at risk
10 mg to 40 mg of olmesartan (OM) was administered as oral suspension or tablets depending on participant weight and response. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
|
Cohort B: Period 2 High Dose OM
n=56 participants at risk
For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 20 mg or 40 mg, depending on weight.
|
Cohort B: Period 2 Low Dose OM
n=56 participants at risk
For Cohort B (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 2.5 mg or 5 mg, depending on weight.
|
Cohort B: Period 3 OM High Dose Continued
n=26 participants at risk
The 20 mg or 40 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
|
Cohort B: Period 3 Placebo From High Dose
n=28 participants at risk
Placebo was given instead of the previous high dose of olmesartan
|
Cohort B: Period 3 OM Low Dose Continued
n=27 participants at risk
The 2.5 mg or 5 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
|
Cohort B: Period 3 Placebo From Low Dose
n=26 participants at risk
Placebo was given instead of the previous low dose of olmesartan
|
Cohort B: Period 4 Open-label OM
n=103 participants at risk；n=104 participants at risk
10 mg to 40 mg of olmesartan (OM) was administered as oral suspension or tablets depending on particpant weight and response. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
|
Cohort C: Period 2 Open-label OM
n=59 participants at risk
The dose of olmesartan medoxomil suspension (OM) was 0.3 mg/kg for all particpants who were 1 to 5 years of age.
|
Cohort C: Period 3 OM Dose Continued
n=29 participants at risk
The 0.3 mg/kg dose of OM was continued for these participants
|
Cohort C: Period 3 Placebo
n=28 participants at risk；n=29 participants at risk
The 0.3 mg/kg dose of olmesartan medoxomil suspension (OM) was discontinued for these participants. They were switched to placebo.
|
Cohort C: Period 4 Open-label OM
n=57 participants at risk
Participants received an olmesartan medoxomil suspension (OM) starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hypoproteinemia
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.56%
1/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Infections and infestations
Abcess limb
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.96%
1/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
General disorders
Anasarca
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.56%
1/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.1%
2/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.96%
1/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.56%
1/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Infections and infestations
Broncopneumonia
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.7%
3/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.5%
2/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Congenital, familial and genetic disorders
Coarctation of the aorta
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.56%
1/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Psychiatric disorders
Depression
|
1.1%
1/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.1%
1/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.96%
1/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Eye disorders
Eye hemorrhage
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.8%
1/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Investigations
Laparoscopy
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.56%
1/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.56%
1/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.56%
1/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Eye disorders
Ophthalmoplegia
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.56%
1/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.9%
2/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.8%
1/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.8%
1/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Gastrointestinal disorders
Peritonitis
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.96%
1/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.8%
1/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.8%
1/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.1%
2/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.56%
1/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.56%
1/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.96%
1/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Infections and infestations
Upper respiratory infection
|
1.1%
1/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.56%
1/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
—
0/0 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.1%
2/179 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
—
0/0 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/104 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
Other adverse events
| Measure |
Cohort A: Period 2 High Dose OM
n=95 participants at risk
For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 20 mg or 40 mg, depending on weight.
|
Cohort A: Period 2 Low Dose OM
n=95 participants at risk
For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 2.5 mg or 5 mg, depending on weight.
|
Cohort A: Period 3 OM High Dose Continued
n=48 participants at risk
The 20 mg or 40 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
|
Cohort A: Period 3 Placebo From High Dose
n=45 participants at risk
Placebo was given instead of the previous high dose of olmesartan
|
Cohort A: Period 3 OM Low Dose Continued
n=45 participants at risk
The 2.5 mg or 5 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
|
Cohort A: Period 3 Placebo From Low Dose
n=44 participants at risk
Placebo was given instead of the previous low dose of olmesartan
|
Cohort A: Period 4 Open-label OM
n=178 participants at risk；n=179 participants at risk
10 mg to 40 mg of olmesartan (OM) was administered as oral suspension or tablets depending on participant weight and response. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
|
Cohort B: Period 2 High Dose OM
n=56 participants at risk
For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 20 mg or 40 mg, depending on weight.
|
Cohort B: Period 2 Low Dose OM
n=56 participants at risk
For Cohort B (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 2.5 mg or 5 mg, depending on weight.
|
Cohort B: Period 3 OM High Dose Continued
n=26 participants at risk
The 20 mg or 40 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
|
Cohort B: Period 3 Placebo From High Dose
n=28 participants at risk
Placebo was given instead of the previous high dose of olmesartan
|
Cohort B: Period 3 OM Low Dose Continued
n=27 participants at risk
The 2.5 mg or 5 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
|
Cohort B: Period 3 Placebo From Low Dose
n=26 participants at risk
Placebo was given instead of the previous low dose of olmesartan
|
Cohort B: Period 4 Open-label OM
n=103 participants at risk；n=104 participants at risk
10 mg to 40 mg of olmesartan (OM) was administered as oral suspension or tablets depending on particpant weight and response. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
|
Cohort C: Period 2 Open-label OM
n=59 participants at risk
The dose of olmesartan medoxomil suspension (OM) was 0.3 mg/kg for all particpants who were 1 to 5 years of age.
|
Cohort C: Period 3 OM Dose Continued
n=29 participants at risk
The 0.3 mg/kg dose of OM was continued for these participants
|
Cohort C: Period 3 Placebo
n=28 participants at risk；n=29 participants at risk
The 0.3 mg/kg dose of olmesartan medoxomil suspension (OM) was discontinued for these participants. They were switched to placebo.
|
Cohort C: Period 4 Open-label OM
n=57 participants at risk
Participants received an olmesartan medoxomil suspension (OM) starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.2%
3/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
5.3%
5/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
5.6%
10/178 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.8%
1/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
8.7%
9/103 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
General disorders
Pyrexia
|
4.2%
4/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
4.2%
4/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
6.2%
3/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
9.0%
16/178 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.8%
1/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.9%
2/103 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
5.1%
3/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
12.3%
7/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Infections and infestations
Nasopharyngitis
|
1.1%
1/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
4.2%
4/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
9.0%
16/178 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.8%
1/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.6%
2/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.9%
4/103 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.7%
1/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
7.1%
2/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.5%
2/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.4%
7/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
4.2%
4/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
11.2%
20/178 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.6%
2/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
2.9%
3/103 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.7%
1/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.4%
1/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
19.3%
11/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Nervous system disorders
Dizziness
|
9.5%
9/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
2.1%
2/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
5.6%
10/178 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.8%
1/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.9%
2/103 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.6%
1/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Nervous system disorders
Headache
|
14.7%
14/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
7.4%
7/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
8.3%
4/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
2.2%
1/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
6.7%
3/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
4.5%
2/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
16.9%
30/178 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
8.9%
5/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
5.4%
3/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
7.7%
2/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.7%
1/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.8%
1/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
17.5%
18/103 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.7%
1/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.8%
1/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.1%
1/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
6.3%
6/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
4.2%
2/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
2.2%
1/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
2.3%
1/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
6.7%
12/178 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.6%
1/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
2.9%
3/103 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.2%
3/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
6.2%
3/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
6.2%
11/178 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.8%
1/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
6.8%
7/103 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
5.3%
3/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Infections and infestations
Influenza
|
1.1%
1/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
4.5%
2/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
5.6%
10/178 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.6%
2/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.8%
1/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.7%
1/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.9%
4/103 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.7%
1/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.4%
1/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.6%
1/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
5.3%
3/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Infections and infestations
Pharyngitis
|
4.2%
4/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
2.1%
2/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
6.7%
3/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
4.4%
2/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.9%
7/178 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/103 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.5%
2/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Investigations
Blood urea increased
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
4.4%
2/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/178 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/103 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
6.2%
3/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
2.2%
1/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
2.3%
1/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
13.5%
24/178 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.8%
1/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
6.8%
7/103 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
5.1%
3/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.4%
1/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.6%
1/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
8.8%
5/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
2.1%
2/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.2%
3/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
4.4%
2/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
2.2%
4/178 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.8%
1/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.9%
2/103 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
2.1%
2/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.7%
3/178 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.8%
1/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
4.9%
5/103 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.5%
2/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
5.1%
9/178 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.9%
2/103 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
1.1%
1/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
2.1%
2/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.1%
2/178 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
2.9%
3/103 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.7%
1/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.6%
1/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
7.0%
4/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/178 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/103 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.7%
1/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
5.3%
3/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Infections and infestations
Tonsilitis
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/178 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/103 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
8.8%
5/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
2.2%
4/178 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/103 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
7.0%
4/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Infections and infestations
Viral infection
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
2.1%
2/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/178 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/103 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
5.3%
3/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Metabolism and nutrition disorders
Pseudohyperkalemia
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/178 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/103 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
7.1%
2/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/178 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/103 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
8.8%
5/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Renal and urinary disorders
Proteinurea
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/178 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/103 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
5.3%
3/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.4%
6/178 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
1.9%
2/103 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
10.5%
6/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/95 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/48 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/45 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/44 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/178 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/56 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/27 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/26 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/103 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/59 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
3.4%
1/29 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
0.00%
0/28 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
7.0%
4/57 • Adverse events were collected starting with the signing of the informed consent form and continuing through the end of the study (51 weeks)
AEs observed by the investigator, or reported by the subject, and any remedial action taken, were recorded in the case report form by the investigator. The nature of each event, time of onset after drug administration, duration, and intensity were documented together with the investigator's opinion of the causal relationship to the treatment.
|
Additional Information
Howard Kessler, Senior Director Regulatory Operations
Daiichi Sankyo
Phone: 732-590-5032
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If identified by Daiichi Sankyo Inc.(DSI), any of DSI's confidential information, as defined to the author, shall be deleted. Nothing in our site agreement shall be taken as giving DSI any right of editorial control over any publication prepared by the study site.
- Publication restrictions are in place
Restriction type: OTHER