Trial Outcomes & Findings for A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome (NCT NCT04572243)
NCT ID: NCT04572243
Last Updated: 2025-10-08
Results Overview
Seizure frequency for convulsive seizures was based on number of seizures per 28 days, calculated during the baseline period (Week -4 to Week 0) and 14-week treatment period, as the number of seizures during each respective period divided by the number of non-missing days during each respective period, multiplied by 28. Percent change from baseline was calculated as: (\[post-baseline value minus the baseline value\] / baseline value) \*100.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
22 participants
Primary outcome timeframe
Baseline up to Week 14
Results posted on
2025-10-08
Participant Flow
Participants took part at 15 investigative sites in Canada and the United States from 23 September 2020 to 15 August 2024.
The study was conducted in two phases (Core Study and an Open-label Extension Phase). A total of 27 participants were screened, of which 5 were screen failures and 22 were enrolled to receive study treatment. This study was terminated due to sponsor decision, and not due to safety concerns. As pre-planned, the data collection and analysis were based on treatments (placebo or lorcaserin) in Core Study and Extension Phase. The dose level wise data was not collected in this study.
Participant milestones
| Measure |
Core Study: Placebo
Participants received lorcaserin-matching placebo, oral suspension, twice daily for 14 weeks.
|
Core Study: Lorcaserin
Participants weighing 10 to less than (\<) 20 kilogram (kg), 20 to \<40 kg, and greater than or equal to (\>=) 40 kg received lorcaserin oral suspension, at dose of 5 milligrams per day (mg/day), 10 mg/day, and 20 mg/day, respectively. During the first 2 weeks of the treatment, depending on the participant's clinical response and tolerability, the dose was increased up to 10 mg/day for participants weighing 10 to \<20 kg and up to 20 mg/day for those weighing 20 to \<40 kg and \>=40 kg. The total treatment duration in Core Study was 14 weeks.
|
Extension Phase: Placebo Then Lorcaserin
Participants who received placebo in Core Study and entered Extension Phase, received lorcaserin, oral suspension based on body weight as the target dose for participants weighing 10 to \<20 kg, 20 to \<40 kg, and \>=40 kg was 5 mg/day, 10 mg/day, and 20 mg/day, respectively for first 6 weeks in Extension Phase. Based on clinical response and tolerability, the dose was increased up to 10 mg/day for participants weighing 10 to \<20 kg and up to 20 mg/day for those weighing 20 to \<40 kg and \>=40 kg for second 6 weeks in Extension Phase. The total treatment duration in Extension Phase was 12 weeks.
|
Extension Phase: Lorcaserin
Participants who received lorcaserin in Core Study and entered Extension Phase, received lorcaserin at the same dose they were receiving at end of Core Study for first 6 weeks in Extension Phase. Based on clinical response and tolerability, the dose increased up to 10 mg/day for participants weighing 10 to \<20 kg and up to 20 mg/day for those weighing 20 to \<40 kg and \>=40 kg during second 6 weeks in Extension Phase. The total treatment duration in Extension Phase was 12 weeks.
|
|---|---|---|---|---|
|
Core Study: 14 Weeks
STARTED
|
11
|
11
|
0
|
0
|
|
Core Study: 14 Weeks
Treated
|
10
|
11
|
0
|
0
|
|
Core Study: 14 Weeks
COMPLETED
|
8
|
7
|
0
|
0
|
|
Core Study: 14 Weeks
NOT COMPLETED
|
3
|
4
|
0
|
0
|
|
Extension Phase: 12 Weeks
STARTED
|
0
|
0
|
7
|
7
|
|
Extension Phase: 12 Weeks
COMPLETED
|
0
|
0
|
7
|
7
|
|
Extension Phase: 12 Weeks
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Core Study: Placebo
Participants received lorcaserin-matching placebo, oral suspension, twice daily for 14 weeks.
|
Core Study: Lorcaserin
Participants weighing 10 to less than (\<) 20 kilogram (kg), 20 to \<40 kg, and greater than or equal to (\>=) 40 kg received lorcaserin oral suspension, at dose of 5 milligrams per day (mg/day), 10 mg/day, and 20 mg/day, respectively. During the first 2 weeks of the treatment, depending on the participant's clinical response and tolerability, the dose was increased up to 10 mg/day for participants weighing 10 to \<20 kg and up to 20 mg/day for those weighing 20 to \<40 kg and \>=40 kg. The total treatment duration in Core Study was 14 weeks.
|
Extension Phase: Placebo Then Lorcaserin
Participants who received placebo in Core Study and entered Extension Phase, received lorcaserin, oral suspension based on body weight as the target dose for participants weighing 10 to \<20 kg, 20 to \<40 kg, and \>=40 kg was 5 mg/day, 10 mg/day, and 20 mg/day, respectively for first 6 weeks in Extension Phase. Based on clinical response and tolerability, the dose was increased up to 10 mg/day for participants weighing 10 to \<20 kg and up to 20 mg/day for those weighing 20 to \<40 kg and \>=40 kg for second 6 weeks in Extension Phase. The total treatment duration in Extension Phase was 12 weeks.
|
Extension Phase: Lorcaserin
Participants who received lorcaserin in Core Study and entered Extension Phase, received lorcaserin at the same dose they were receiving at end of Core Study for first 6 weeks in Extension Phase. Based on clinical response and tolerability, the dose increased up to 10 mg/day for participants weighing 10 to \<20 kg and up to 20 mg/day for those weighing 20 to \<40 kg and \>=40 kg during second 6 weeks in Extension Phase. The total treatment duration in Extension Phase was 12 weeks.
|
|---|---|---|---|---|
|
Core Study: 14 Weeks
Adverse Event
|
1
|
2
|
0
|
0
|
|
Core Study: 14 Weeks
Subject choice
|
0
|
2
|
0
|
0
|
|
Core Study: 14 Weeks
Withdrawal of consent
|
1
|
0
|
0
|
0
|
|
Core Study: 14 Weeks
Randomized but not treated
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Lorcaserin as Adjunctive Treatment in Participants With Dravet Syndrome
Baseline characteristics by cohort
| Measure |
Placebo/ Lorcaserin
n=10 Participants
Participants received lorcaserin-matching placebo, oral suspension, twice daily for 14 weeks in Core Study followed by lorcaserin, oral suspension based on body weight as the target dose for participants weighing 10 to \<20 kg, 20 to \<40 kg, and \>=40 kg was 5 mg/day, 10 mg/day, and 20 mg/day, respectively for first 6 weeks in Extension Phase. Based on clinical response and tolerability, the dose was increased up to 10 mg/day for participants weighing 10 to \<20 kg and up to 20 mg/day for those weighing 20 to \<40 kg and \>=40 kg for second 6 weeks in Extension Phase. The total treatment duration in Core Study was 14 weeks and 12 weeks in Extension Phase.
|
Lorcaserin/ Lorcaserin
n=11 Participants
Participants weighing 10 to \<20 kg, 20 to \<40 kg, and \>=40 kg received lorcaserin oral suspension, at dose of 5 mg/day, 10 mg/day, and 20 mg/day, respectively in Core Study. During the first 2 weeks of the treatment, depending on the participant's clinical response and tolerability, the dose was increased up to 10 mg/day for participants weighing 10 to \<20 kg and up to 20 mg/day for those weighing 20 to \<40 kg and \>=40 kg. During Extension Phase, participants continued the same dose of Core Study for first 6 weeks in Extension Phase. Based on clinical response and tolerability, the dose increased up to 10 mg/day for participants weighing 10 to \<20 kg and up to 20 mg/day for those weighing 20 to \<40 kg and \>=40 kg during second 6 weeks in Extension Phase. The total treatment duration in Core Study was 14 weeks and 12 weeks in Extension Phase.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.9 year
STANDARD_DEVIATION 10.32 • n=5 Participants
|
12.7 year
STANDARD_DEVIATION 7.71 • n=7 Participants
|
12.8 year
STANDARD_DEVIATION 8.81 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 14Population: The FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement.
Seizure frequency for convulsive seizures was based on number of seizures per 28 days, calculated during the baseline period (Week -4 to Week 0) and 14-week treatment period, as the number of seizures during each respective period divided by the number of non-missing days during each respective period, multiplied by 28. Percent change from baseline was calculated as: (\[post-baseline value minus the baseline value\] / baseline value) \*100.
Outcome measures
| Measure |
Core Study: Placebo
n=10 Participants
Participants received lorcaserin-matching placebo, oral suspension, twice daily for 14 weeks.
|
Core Study: Lorcaserin
n=10 Participants
Participants weighing 10 to \<20 kg, 20 to \<40 kg, and \>=40 kg received lorcaserin oral suspension, at dose of 5 mg/day, 10 mg/day, and 20 mg/day, respectively. During the first 2 weeks of the treatment, depending on the participant's clinical response and tolerability, the dose was increased up to 10 mg/day for participants weighing 10 to \<20 kg and up to 20 mg/day for those weighing 20 to \<40 kg and \>=40 kg. The total treatment duration in Core Study was 14 weeks.
|
|---|---|---|
|
Core Study: Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Treatment Period
|
18.78 percent change
Interval -53.7 to 131.5
|
-78.88 percent change
Interval -100.0 to 542.9
|
SECONDARY outcome
Timeframe: Baseline up to Week 14Population: The FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement.
A responder was defined as a participant who experienced a reduction of 50% or greater in the frequency of convulsive seizures during the 14-week treatment period compared to the baseline period (Week -4 to Week 0). Seizure frequency was based on number of seizures per 28 days, calculated during the baseline period (Week -4 to Week 0) and treatment period, as the number of seizures during each respective period divided by the number of non-missing days during each respective period, multiplied by 28.
Outcome measures
| Measure |
Core Study: Placebo
n=10 Participants
Participants received lorcaserin-matching placebo, oral suspension, twice daily for 14 weeks.
|
Core Study: Lorcaserin
n=10 Participants
Participants weighing 10 to \<20 kg, 20 to \<40 kg, and \>=40 kg received lorcaserin oral suspension, at dose of 5 mg/day, 10 mg/day, and 20 mg/day, respectively. During the first 2 weeks of the treatment, depending on the participant's clinical response and tolerability, the dose was increased up to 10 mg/day for participants weighing 10 to \<20 kg and up to 20 mg/day for those weighing 20 to \<40 kg and \>=40 kg. The total treatment duration in Core Study was 14 weeks.
|
|---|---|---|
|
Core Study: Percentage of Participants With 50% or Greater Response for Convulsive Seizures in the Treatment Period Compared to Baseline
|
20.0 percentage of participants
|
60.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Week 14Population: The FAS was the group of randomized participants who received at least 1 dose of study drug and had at least 1 post-dose primary efficacy measurement.
A responder was a participant who experienced a 100% reduction (seizure freedom) in convulsive seizure frequency in the 14-week treatment period relative to the baseline period (Week -4 to Week 0). Seizure frequency was based on number of seizures per 28 days, calculated during the baseline period (Week -4 to Week 0) and treatment period, as the number of seizures during each respective period divided by the number of non-missing days during each respective period, multiplied by 28.
Outcome measures
| Measure |
Core Study: Placebo
n=10 Participants
Participants received lorcaserin-matching placebo, oral suspension, twice daily for 14 weeks.
|
Core Study: Lorcaserin
n=10 Participants
Participants weighing 10 to \<20 kg, 20 to \<40 kg, and \>=40 kg received lorcaserin oral suspension, at dose of 5 mg/day, 10 mg/day, and 20 mg/day, respectively. During the first 2 weeks of the treatment, depending on the participant's clinical response and tolerability, the dose was increased up to 10 mg/day for participants weighing 10 to \<20 kg and up to 20 mg/day for those weighing 20 to \<40 kg and \>=40 kg. The total treatment duration in Core Study was 14 weeks.
|
|---|---|---|
|
Core Study: Percentage of Participants Who Were Free From Convulsive Seizures in the Treatment Period
|
0.0 percentage of participants
|
10.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 1, 2, 6, 15: Pre-dose and 1 to 2 hours post-dose; Weeks 4,10: Pre-dose, 1 to 2 hours and 3 to 6 hours post-dosePopulation: The Pharmacokinetic (PK) analysis set was the group of all randomized participants from whom at least measurable lorcaserin plasma concentration was obtained with associated documented dosing history. Here 'n' refers to number of participants analyzed at different timepoints for this outcome measure.
Plasma Concentrations of Lorcaserin was evaluated and reported.
Outcome measures
| Measure |
Core Study: Placebo
n=7 Participants
Participants received lorcaserin-matching placebo, oral suspension, twice daily for 14 weeks.
|
Core Study: Lorcaserin
Participants weighing 10 to \<20 kg, 20 to \<40 kg, and \>=40 kg received lorcaserin oral suspension, at dose of 5 mg/day, 10 mg/day, and 20 mg/day, respectively. During the first 2 weeks of the treatment, depending on the participant's clinical response and tolerability, the dose was increased up to 10 mg/day for participants weighing 10 to \<20 kg and up to 20 mg/day for those weighing 20 to \<40 kg and \>=40 kg. The total treatment duration in Core Study was 14 weeks.
|
|---|---|---|
|
Core Study: Plasma Concentrations of Lorcaserin
Week 1: Pre-dose
|
52.0 nanograms per milliliter (ng/mL)
Standard Deviation NA
Standard deviation could not be derived as the analysis was based on a single participant
|
—
|
|
Core Study: Plasma Concentrations of Lorcaserin
Week 1: 1 to 2 hours post-dose
|
106 nanograms per milliliter (ng/mL)
Standard Deviation NA
Standard deviation could not be derived as the analysis was based on a single participant
|
—
|
|
Core Study: Plasma Concentrations of Lorcaserin
Week 2: Pre-dose
|
22.1 nanograms per milliliter (ng/mL)
Standard Deviation 14.5
|
—
|
|
Core Study: Plasma Concentrations of Lorcaserin
Week 2: 1 to 2 hours post-dose
|
32.7 nanograms per milliliter (ng/mL)
Standard Deviation 22.7
|
—
|
|
Core Study: Plasma Concentrations of Lorcaserin
Week 4: Pre-dose
|
48.5 nanograms per milliliter (ng/mL)
Standard Deviation 13.2
|
—
|
|
Core Study: Plasma Concentrations of Lorcaserin
Week 4: 1 to 2 hours post-dose
|
107 nanograms per milliliter (ng/mL)
Standard Deviation 76.9
|
—
|
|
Core Study: Plasma Concentrations of Lorcaserin
Week 4: 3 to 6 hours post-dose
|
60.5 nanograms per milliliter (ng/mL)
Standard Deviation 36.0
|
—
|
|
Core Study: Plasma Concentrations of Lorcaserin
Week 6: Pre-dose
|
22.7 nanograms per milliliter (ng/mL)
Standard Deviation 11.8
|
—
|
|
Core Study: Plasma Concentrations of Lorcaserin
Week 6: 1 to 2 hours post-dose
|
41.0 nanograms per milliliter (ng/mL)
Standard Deviation 20.6
|
—
|
|
Core Study: Plasma Concentrations of Lorcaserin
Week 10: Pre-dose
|
32.9 nanograms per milliliter (ng/mL)
Standard Deviation NA
Standard deviation could not be derived as the analysis was based on a single participant
|
—
|
|
Core Study: Plasma Concentrations of Lorcaserin
Week 10: 1 to 2 hours post-dose
|
52.4 nanograms per milliliter (ng/mL)
Standard Deviation NA
Standard deviation could not be derived as the analysis was based on a single participant
|
—
|
|
Core Study: Plasma Concentrations of Lorcaserin
Week 10: 3 to 6 hours post-dose
|
66.7 nanograms per milliliter (ng/mL)
Standard Deviation 33.7
|
—
|
|
Core Study: Plasma Concentrations of Lorcaserin
Week 15: Pre-dose
|
33.6 nanograms per milliliter (ng/mL)
Standard Deviation NA
Standard deviation could not be derived as the analysis was based on a single participant
|
—
|
|
Core Study: Plasma Concentrations of Lorcaserin
Week 15: 1 to 2 hours post-dose
|
31.4 nanograms per milliliter (ng/mL)
Standard Deviation NA
Standard deviation could not be derived as the analysis was based on a single participant
|
—
|
SECONDARY outcome
Timeframe: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18)Population: The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
A TEAE was defined as an adverse event (AE) that emerges during treatment, was absent at pretreatment (baseline) or reemerges during treatment, was present at pretreatment (baseline) but stopped before treatment or worsens in severity during treatment relative to the pretreatment state, when the AE was continuous. An AE was any untoward medical occurrence in a participant or clinical investigation participant administered an investigational product. An AE did not necessarily have a causal relationship with the medicinal product.
Outcome measures
| Measure |
Core Study: Placebo
n=10 Participants
Participants received lorcaserin-matching placebo, oral suspension, twice daily for 14 weeks.
|
Core Study: Lorcaserin
n=11 Participants
Participants weighing 10 to \<20 kg, 20 to \<40 kg, and \>=40 kg received lorcaserin oral suspension, at dose of 5 mg/day, 10 mg/day, and 20 mg/day, respectively. During the first 2 weeks of the treatment, depending on the participant's clinical response and tolerability, the dose was increased up to 10 mg/day for participants weighing 10 to \<20 kg and up to 20 mg/day for those weighing 20 to \<40 kg and \>=40 kg. The total treatment duration in Core Study was 14 weeks.
|
|---|---|---|
|
Core Study: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
7 Participants
|
9 Participants
|
Adverse Events
Core Study: Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Core Study: Lorcaserin
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Extension Phase: Placebo Then Lorcaserin
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Extension Phase: Lorcaserin
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Core Study: Placebo
n=10 participants at risk
Participants received lorcaserin-matching placebo, oral suspension, twice daily for 14 weeks.
|
Core Study: Lorcaserin
n=11 participants at risk
Participants weighing 10 to \<20 kg, 20 to \<40 kg, and \>=40 kg received lorcaserin oral suspension, at dose of 5 mg/day, 10 mg/day, and 20 mg/day, respectively. During the first 2 weeks of the treatment, depending on the participant's clinical response and tolerability, the dose was increased up to 10 mg/day for participants weighing 10 to \<20 kg and up to 20 mg/day for those weighing 20 to \<40 kg and \>=40 kg. The total treatment duration in Core Study was 14 weeks.
|
Extension Phase: Placebo Then Lorcaserin
n=7 participants at risk
Participants who received placebo in Core Study and entered Extension Phase, received lorcaserin, oral suspension based on body weight as the target dose for participants weighing 10 to \<20 kg, 20 to \<40 kg, and \>=40 kg was 5 mg/day, 10 mg/day, and 20 mg/day, respectively for first 6 weeks in Extension Phase. Based on clinical response and tolerability, the dose was increased up to 10 mg/day for participants weighing 10 to \<20 kg and up to 20 mg/day for those weighing 20 to \<40 kg and \>=40 kg for second 6 weeks in Extension Phase. The total treatment duration in Extension Phase was 12 weeks.
|
Extension Phase: Lorcaserin
n=7 participants at risk
Participants who received lorcaserin in Core Study and entered Extension Phase, received lorcaserin at the same dose they were receiving at end of Core Study for first 6 weeks in Extension Phase. Based on clinical response and tolerability, the dose increased up to 10 mg/day for participants weighing 10 to \<20 kg and up to 20 mg/day for those weighing 20 to \<40 kg and \>=40 kg during second 6 weeks in Extension Phase. The total treatment duration in Extension Phase was 12 weeks.
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
9.1%
1/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
General disorders
Pyrexia
|
0.00%
0/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
14.3%
1/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
Other adverse events
| Measure |
Core Study: Placebo
n=10 participants at risk
Participants received lorcaserin-matching placebo, oral suspension, twice daily for 14 weeks.
|
Core Study: Lorcaserin
n=11 participants at risk
Participants weighing 10 to \<20 kg, 20 to \<40 kg, and \>=40 kg received lorcaserin oral suspension, at dose of 5 mg/day, 10 mg/day, and 20 mg/day, respectively. During the first 2 weeks of the treatment, depending on the participant's clinical response and tolerability, the dose was increased up to 10 mg/day for participants weighing 10 to \<20 kg and up to 20 mg/day for those weighing 20 to \<40 kg and \>=40 kg. The total treatment duration in Core Study was 14 weeks.
|
Extension Phase: Placebo Then Lorcaserin
n=7 participants at risk
Participants who received placebo in Core Study and entered Extension Phase, received lorcaserin, oral suspension based on body weight as the target dose for participants weighing 10 to \<20 kg, 20 to \<40 kg, and \>=40 kg was 5 mg/day, 10 mg/day, and 20 mg/day, respectively for first 6 weeks in Extension Phase. Based on clinical response and tolerability, the dose was increased up to 10 mg/day for participants weighing 10 to \<20 kg and up to 20 mg/day for those weighing 20 to \<40 kg and \>=40 kg for second 6 weeks in Extension Phase. The total treatment duration in Extension Phase was 12 weeks.
|
Extension Phase: Lorcaserin
n=7 participants at risk
Participants who received lorcaserin in Core Study and entered Extension Phase, received lorcaserin at the same dose they were receiving at end of Core Study for first 6 weeks in Extension Phase. Based on clinical response and tolerability, the dose increased up to 10 mg/day for participants weighing 10 to \<20 kg and up to 20 mg/day for those weighing 20 to \<40 kg and \>=40 kg during second 6 weeks in Extension Phase. The total treatment duration in Extension Phase was 12 weeks.
|
|---|---|---|---|---|
|
Eye disorders
Dacryostenosis acquired
|
0.00%
0/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
9.1%
1/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
9.1%
1/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
General disorders
Fatigue
|
0.00%
0/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
9.1%
1/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
General disorders
Pyrexia
|
10.0%
1/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
18.2%
2/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
14.3%
1/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
Infections and infestations
COVID-19
|
20.0%
2/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
Infections and infestations
Ear infection
|
10.0%
1/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
9.1%
1/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
9.1%
1/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
Infections and infestations
Nasopharyngitis
|
10.0%
1/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
14.3%
1/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
9.1%
1/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
Infections and infestations
Pharyngitis streptococcal
|
10.0%
1/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
9.1%
1/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.0%
1/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
9.1%
1/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
14.3%
1/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
9.1%
1/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
Investigations
Body temperature decreased
|
10.0%
1/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.0%
1/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
27.3%
3/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
1/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
9.1%
1/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
Nervous system disorders
Seizure
|
10.0%
1/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
Psychiatric disorders
Aggression
|
10.0%
1/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
9.1%
1/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
1/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
14.3%
1/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
14.3%
1/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
9.1%
1/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
14.3%
1/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
General disorders
Gait disturbance
|
0.00%
0/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
14.3%
1/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
General disorders
Sluggishness
|
0.00%
0/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
14.3%
1/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
General disorders
Thirst
|
0.00%
0/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
14.3%
1/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
Infections and infestations
Viral infection
|
0.00%
0/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
14.3%
1/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
14.3%
1/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/10 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/11 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
0.00%
0/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
14.3%
1/7 • Core Study: From first dose of study drug up to end of 4 weeks of follow up after last dose of study drug (up to Week 18); Extension Phase: From first dose of study drug in Extension Phase (Week 15) up to end of 4 weeks of follow up after last dose of study drug (up to Week 30)
The Safety Analysis Set was the group of participants who received at least 1 dose of study drug and had at least 1 postdose safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place