Trial Outcomes & Findings for Study of Losartan in Pediatric Patients With Hypertension (MK-0954-337) (NCT NCT00756938)
NCT ID: NCT00756938
Last Updated: 2024-06-18
Results Overview
Sitting blood pressure (\[BP\] or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Systolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
101 participants
Primary outcome timeframe
Baseline and Day 21
Results posted on
2024-06-18
Participant Flow
Participant milestones
| Measure |
Losartan Potassium 0.1 to 1.4 mg/kg
Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
|
Losartan Potassium 0.3 to 1.4 mg/kg
Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
|
Losartan Potassium 0.7 to 1.4 mg/kg
Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
|
Losartan Potassium-Extension
Participants who elected to enter extension; dose level of Losartan was that which was being administered at end of base study
|
|---|---|---|---|---|
|
12-week Base Study
STARTED
|
33
|
34
|
34
|
0
|
|
12-week Base Study
COMPLETED
|
31
|
34
|
32
|
0
|
|
12-week Base Study
NOT COMPLETED
|
2
|
0
|
2
|
0
|
|
Optional Extension
STARTED
|
0
|
0
|
0
|
90
|
|
Optional Extension
COMPLETED
|
0
|
0
|
0
|
53
|
|
Optional Extension
NOT COMPLETED
|
0
|
0
|
0
|
37
|
Reasons for withdrawal
| Measure |
Losartan Potassium 0.1 to 1.4 mg/kg
Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
|
Losartan Potassium 0.3 to 1.4 mg/kg
Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
|
Losartan Potassium 0.7 to 1.4 mg/kg
Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
|
Losartan Potassium-Extension
Participants who elected to enter extension; dose level of Losartan was that which was being administered at end of base study
|
|---|---|---|---|---|
|
12-week Base Study
Protocol-specific Criteria Met
|
1
|
0
|
1
|
0
|
|
12-week Base Study
Protocol Violation
|
0
|
0
|
1
|
0
|
|
12-week Base Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
|
Optional Extension
Lack of Efficacy
|
0
|
0
|
0
|
1
|
|
Optional Extension
End of Study
|
0
|
0
|
0
|
11
|
|
Optional Extension
Protocol-specific criteria met
|
0
|
0
|
0
|
9
|
|
Optional Extension
Physician Decision
|
0
|
0
|
0
|
3
|
|
Optional Extension
Lost to Follow-up
|
0
|
0
|
0
|
1
|
|
Optional Extension
Protocol Violation
|
0
|
0
|
0
|
1
|
|
Optional Extension
Withdrawal by Subject
|
0
|
0
|
0
|
10
|
|
Optional Extension
Adverse Event
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study of Losartan in Pediatric Patients With Hypertension (MK-0954-337)
Baseline characteristics by cohort
| Measure |
Losartan Potassium 0.1 to 1.4 mg/kg
n=33 Participants
Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
|
Losartan Potassium 0.3 to 1.4 mg/kg
n=34 Participants
Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
|
Losartan Potassium 0.7 to 1.4 mg/kg
n=34 Participants
Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.2 Months
STANDARD_DEVIATION 24.4 • n=93 Participants
|
45.0 Months
STANDARD_DEVIATION 21.5 • n=4 Participants
|
40.6 Months
STANDARD_DEVIATION 21.2 • n=27 Participants
|
42.0 Months
STANDARD_DEVIATION 22.3 • n=483 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
16 Participants
n=4 Participants
|
14 Participants
n=27 Participants
|
43 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
58 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 21Population: Analysis performed using the Full Analysis Set defined as all randomized participants who had at least 1 dose of study drug, had baseline data, and had a post-treatment endpoint observation
Sitting blood pressure (\[BP\] or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Systolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.
Outcome measures
| Measure |
Losartan Potassium 0.1 to 1.4 mg/kg
n=32 Participants
Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
|
Losartan Potassium 0.3 to 1.4 mg/kg
n=34 Participants
Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
|
Losartan Potassium 0.7 to 1.4 mg/kg
n=33 Participants
Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
|
Base Study-Losartan Potassium 1.4 mg/kg
Open-label losartan 1.4 mg/kg/day
|
Extension-Losartan Potassium
Open-label losartan at dose of 0.1, .03, .07 or 1.4 mg/kg/day
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Systolic Blood Pressure
|
-7.31 mmHg
Standard Deviation 12.53
|
-7.65 mmHg
Standard Deviation 7.49
|
-6.67 mmHg
Standard Deviation 7.86
|
—
|
—
|
PRIMARY outcome
Timeframe: up to 12 weeks (Base Study); up to 24 months (Extension)Population: All Patients as Treated Population, which consisted of all randomized participants who received at least 1 dose of study drug. Adverse events for the base study were reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. Adverse events for the study extension were reported as 1 arm.
Outcome measures
| Measure |
Losartan Potassium 0.1 to 1.4 mg/kg
n=34 Participants
Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
|
Losartan Potassium 0.3 to 1.4 mg/kg
n=54 Participants
Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
|
Losartan Potassium 0.7 to 1.4 mg/kg
n=63 Participants
Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
|
Base Study-Losartan Potassium 1.4 mg/kg
n=33 Participants
Open-label losartan 1.4 mg/kg/day
|
Extension-Losartan Potassium
n=90 Participants
Open-label losartan at dose of 0.1, .03, .07 or 1.4 mg/kg/day
|
|---|---|---|---|---|---|
|
Number of Participants Who Reported 1 or More Clinical and/or Laboratory Adverse Event(s)
Clinical Adverse Event
|
21 Participants
|
30 Participants
|
36 Participants
|
22 Participants
|
75 Participants
|
|
Number of Participants Who Reported 1 or More Clinical and/or Laboratory Adverse Event(s)
Laboratory Adverse Event
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: up to 12 weeks (Base Study); up to 24 months (Extension)Population: All Patients as Treated Population, which consisted of all randomized participants who received at least 1 dose of study drug. Adverse events for the base study were reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. Adverse events for the study extension were reported as 1 arm.
Outcome measures
| Measure |
Losartan Potassium 0.1 to 1.4 mg/kg
n=34 Participants
Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
|
Losartan Potassium 0.3 to 1.4 mg/kg
n=54 Participants
Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
|
Losartan Potassium 0.7 to 1.4 mg/kg
n=63 Participants
Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
|
Base Study-Losartan Potassium 1.4 mg/kg
n=33 Participants
Open-label losartan 1.4 mg/kg/day
|
Extension-Losartan Potassium
n=90 Participants
Open-label losartan at dose of 0.1, .03, .07 or 1.4 mg/kg/day
|
|---|---|---|---|---|---|
|
Number of Participants Who Were Discontinued From Study Due to a Clinical and/or Laboratory Adverse Event
Laboratory Adverse Event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Who Were Discontinued From Study Due to a Clinical and/or Laboratory Adverse Event
Clinical Adverse Event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and Day 21Population: Analysis performed using the Full Analysis Set defined as all randomized participants who had at least 1 dose of study drug, had baseline data, and had a post-treatment endpoint observation
Sitting BP (or supine if child could not sit) was measured after the participant had been seated for 5 minutes with back supported, feet on the floor and right arm (or left arm if it was the customary side for BP measurement for the patient) supported at heart level. Diastolic BP was determined by averaging 3 replicate measurements obtained at least 1 minute apart.
Outcome measures
| Measure |
Losartan Potassium 0.1 to 1.4 mg/kg
n=32 Participants
Open-label losartan at starting dose of 0.1 mg/kg/day with uptitration at Weeks 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
|
Losartan Potassium 0.3 to 1.4 mg/kg
n=34 Participants
Open-label losartan at starting dose of 0.3 mg/kg/day with uptitration at Weeks 3, 6 or 9 to the next highest dose level if blood pressure goal not achieved
|
Losartan Potassium 0.7 to 1.4 mg/kg
n=33 Participants
Open-label losartan at starting dose of 0.7 mg/kg/day with uptitration at Week 3, 6, or 9 to the next highest dose level if blood pressure goal not achieved
|
Base Study-Losartan Potassium 1.4 mg/kg
Open-label losartan 1.4 mg/kg/day
|
Extension-Losartan Potassium
Open-label losartan at dose of 0.1, .03, .07 or 1.4 mg/kg/day
|
|---|---|---|---|---|---|
|
Mean Change From Baseline in Diastolic Blood Pressure
|
-8.25 mmHg
Standard Deviation 11.76
|
-5.15 mmHg
Standard Deviation 8.06
|
-6.73 mmHg
Standard Deviation 8.59
|
—
|
—
|
Adverse Events
Base Study-Losartan Potassium 0.1 mg/kg/Day
Serious events: 3 serious events
Other events: 15 other events
Deaths: 0 deaths
Base Study-Losartan Potassium 0.3 mg/kg/Day
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Base Study-Losartan Potassium 0.7 mg/kg/Day
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Base Study-Losartan 1.4 mg/kg/Day
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Extension-Losartan 0.1 mg/kg/Day
Serious events: 3 serious events
Other events: 12 other events
Deaths: 0 deaths
Extension-Losartan 0.3 mg/kg/Day
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
Extension-Losartan 0.7 mg/kg/Day
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Extension-Losartan 1.4 mg/kg/Day
Serious events: 5 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Base Study-Losartan Potassium 0.1 mg/kg/Day
n=34 participants at risk
|
Base Study-Losartan Potassium 0.3 mg/kg/Day
n=54 participants at risk
|
Base Study-Losartan Potassium 0.7 mg/kg/Day
n=63 participants at risk
|
Base Study-Losartan 1.4 mg/kg/Day
n=33 participants at risk
|
Extension-Losartan 0.1 mg/kg/Day
n=15 participants at risk
|
Extension-Losartan 0.3 mg/kg/Day
n=28 participants at risk
|
Extension-Losartan 0.7 mg/kg/Day
n=31 participants at risk
|
Extension-Losartan 1.4 mg/kg/Day
n=42 participants at risk
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Sinusitis
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
2.4%
1/42 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.7%
1/15 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.7%
1/15 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
General disorders
Asthenia
|
2.9%
1/34 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Adenoiditis
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.2%
1/31 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
1.6%
1/63 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.7%
1/15 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
7.1%
2/28 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.2%
1/31 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
2.4%
1/42 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
1.9%
1/54 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.7%
1/15 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
2.4%
1/42 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
2.4%
1/42 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Pyelonephritis acute
|
2.9%
1/34 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
1.6%
1/63 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.2%
1/31 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.7%
1/15 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Sepsis
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
2.4%
1/42 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
2.4%
1/42 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.7%
1/15 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Urinary tract infection
|
2.9%
1/34 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
1.9%
1/54 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.2%
1/31 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
2.4%
1/42 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
2.9%
1/34 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.2%
1/31 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.6%
1/28 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.6%
1/28 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nephroblastoma
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.6%
1/28 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Psychiatric disorders
Psychomotor retardation
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.6%
1/28 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
2.4%
1/42 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.6%
1/28 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.6%
1/28 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
2.4%
1/42 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
Other adverse events
| Measure |
Base Study-Losartan Potassium 0.1 mg/kg/Day
n=34 participants at risk
|
Base Study-Losartan Potassium 0.3 mg/kg/Day
n=54 participants at risk
|
Base Study-Losartan Potassium 0.7 mg/kg/Day
n=63 participants at risk
|
Base Study-Losartan 1.4 mg/kg/Day
n=33 participants at risk
|
Extension-Losartan 0.1 mg/kg/Day
n=15 participants at risk
|
Extension-Losartan 0.3 mg/kg/Day
n=28 participants at risk
|
Extension-Losartan 0.7 mg/kg/Day
n=31 participants at risk
|
Extension-Losartan 1.4 mg/kg/Day
n=42 participants at risk
|
|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Conjunctivitis
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.7%
2/54 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
1.6%
1/63 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
13.3%
2/15 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.5%
2/31 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
2.4%
1/42 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
2/34 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
1.9%
1/54 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.7%
1/15 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.6%
1/28 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.2%
1/31 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
2.4%
1/42 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.7%
1/15 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.6%
1/28 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
2/34 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
5.6%
3/54 • Number of events 3 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.3%
4/63 • Number of events 4 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.1%
2/33 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
20.0%
3/15 • Number of events 4 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
10.7%
3/28 • Number of events 5 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
16.1%
5/31 • Number of events 5 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
14.3%
6/42 • Number of events 8 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Gastrointestinal disorders
Vomiting
|
2.9%
1/34 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
1.9%
1/54 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
1.6%
1/63 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.0%
1/33 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.6%
1/28 • Number of events 7 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.5%
2/31 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
7.1%
3/42 • Number of events 3 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
General disorders
Pyrexia
|
8.8%
3/34 • Number of events 3 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
7.4%
4/54 • Number of events 6 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
4.8%
3/63 • Number of events 3 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.0%
1/33 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.7%
1/15 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
14.3%
4/28 • Number of events 5 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.5%
2/31 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
9.5%
4/42 • Number of events 10 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.7%
1/15 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.7%
1/15 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.6%
1/28 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
13.3%
2/15 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.6%
1/28 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.2%
1/31 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.7%
2/54 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.0%
1/33 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
7.1%
2/28 • Number of events 3 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
4.8%
2/42 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Ear infection
|
2.9%
1/34 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
1.6%
1/63 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.7%
1/15 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.2%
1/31 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
2.4%
1/42 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.7%
1/15 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
7.1%
3/42 • Number of events 3 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
1.9%
1/54 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
7.1%
2/28 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Impetigo
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
1.9%
1/54 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.5%
2/31 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.7%
1/15 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
2.4%
1/42 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.7%
1/15 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.6%
1/28 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
2.4%
1/42 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
2/34 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
13.0%
7/54 • Number of events 7 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
4.8%
3/63 • Number of events 3 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.1%
2/33 • Number of events 3 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
13.3%
2/15 • Number of events 3 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
14.3%
4/28 • Number of events 6 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
16.1%
5/31 • Number of events 6 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
4.8%
2/42 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.7%
1/15 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.2%
1/31 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
1.9%
1/54 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.7%
1/15 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.6%
1/28 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.5%
2/31 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
4.8%
2/42 • Number of events 3 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Pharyngitis
|
8.8%
3/34 • Number of events 3 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.7%
2/54 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
1.6%
1/63 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.0%
1/33 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
26.7%
4/15 • Number of events 5 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.6%
1/28 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
2.4%
1/42 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Respiratory tract infection
|
5.9%
2/34 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
1.9%
1/54 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
7.9%
5/63 • Number of events 6 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
9.1%
3/33 • Number of events 3 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
13.3%
2/15 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
10.7%
3/28 • Number of events 3 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
9.7%
3/31 • Number of events 6 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
11.9%
5/42 • Number of events 13 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Rhinitis
|
2.9%
1/34 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
5.6%
3/54 • Number of events 3 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.6%
1/28 • Number of events 4 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.2%
1/31 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
1.6%
1/63 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.5%
2/31 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
11.9%
5/42 • Number of events 6 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Tonsillitis
|
2.9%
1/34 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.0%
1/33 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
13.3%
2/15 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.6%
1/28 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.2%
1/31 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
4.8%
2/42 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.9%
1/34 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
5.6%
3/54 • Number of events 3 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.2%
2/63 • Number of events 3 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.7%
1/15 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
14.3%
4/28 • Number of events 4 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
9.7%
3/31 • Number of events 8 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
9.5%
4/42 • Number of events 4 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
2/34 • Number of events 3 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.7%
2/54 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.3%
4/63 • Number of events 4 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
12.1%
4/33 • Number of events 4 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.6%
1/28 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
9.7%
3/31 • Number of events 12 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
16.7%
7/42 • Number of events 13 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Infections and infestations
Viral infection
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.0%
1/33 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
7.1%
2/28 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
2.4%
1/42 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
7.1%
2/28 • Number of events 3 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.2%
1/31 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip and/or oral cavity cancer stage III
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.7%
1/15 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Nervous system disorders
Headache
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
1.9%
1/54 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
1.6%
1/63 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.0%
1/33 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
10.7%
3/28 • Number of events 3 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
2.4%
1/42 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Renal and urinary disorders
Enuresis
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.7%
1/15 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Renal and urinary disorders
Nephrocalcinosis
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.7%
1/15 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.9%
2/34 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.7%
2/54 • Number of events 3 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.2%
2/63 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
15.2%
5/33 • Number of events 5 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.7%
1/15 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.6%
1/28 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
9.7%
3/31 • Number of events 3 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
11.9%
5/42 • Number of events 9 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
1.6%
1/63 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.0%
1/33 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.7%
1/15 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.7%
2/54 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
1.6%
1/63 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.1%
2/33 • Number of events 5 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
13.3%
2/15 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.6%
1/28 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
9.5%
4/42 • Number of events 4 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Vascular disorders
Hypertension
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
1.9%
1/54 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
1.6%
1/63 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.7%
1/15 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Vascular disorders
Hypotension
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
1.6%
1/63 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.7%
1/15 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Investigations
Protein urine present
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.6%
1/28 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.5%
2/31 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
2.4%
1/42 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.5%
2/31 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Investigations
Urine leukocyte esterase positive
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
1.9%
1/54 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
3.6%
1/28 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.5%
2/31 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
1.9%
1/54 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/15 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.5%
2/31 • Number of events 2 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/34 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/54 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/63 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/33 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
6.7%
1/15 • Number of events 1 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/28 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/31 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
0.00%
0/42 • up to 12 weeks (Base Study); up to 24 months (Extension)
Serious and Non-serious adverse events are reported by the dose taken at the time of the event and not the study group to which they were randomly assigned. A participant may have reported a serious/adverse event when taking different dose levels and therefore may have been counted more than once.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Subsequent to the multicenter publication, or 24 months after completion of the study, whichever comes first, an investigator and/or his/her colleagues may publish the results for their study site independently. The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission.
- Publication restrictions are in place
Restriction type: OTHER