Trial Outcomes & Findings for A Study to Evaluate Leuprolide Acetate 45 mg 6-Month Formulation in Children With Central Precocious Puberty (CPP) (NCT NCT03695237)
NCT ID: NCT03695237
Last Updated: 2024-05-29
Results Overview
Suppression of GnRHa-stimulated luteinizing hormone (LH) was measured using a peak GnRHa stimulation test, performed using subcutaneous injection with an aqueous formulation of leuprolide acetate at 20 µg/kg. Peak stimulated LH was calculated by taking the maximum LH concentrations measured from blood samples taken at 30 or 60 min following the GnRHa stimulation test. Suppression of GnRHa-stimulated luteinizing hormone is defined as peak stimulated LH less than 4 mIU/mL.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
45 participants
Primary outcome timeframe
Week 24 (prior to the Week 24 dose); samples for LH measurement were taken 30 and 60 minutes after the stimulation test injection.
Results posted on
2024-05-29
Participant Flow
Participants were enrolled at 16 sites in the United States including Puerto Rico. The study enrolled pediatric participants with central precocious puberty (CPP) who were either naïve to treatment with a gonadotropin-releasing hormone receptor agonist (GnRHa) or who had been previously treated with a GnRHa.
The study was conducted in 2 parts. In Part 1, leuprolide acetate (LA) 45 mg 6-month depot formulation was evaluated from Baseline to Week 48. Following completion of Part 1 assessments, participants continued in Part 2 (extension period) to evaluate long-term treatment of LA 45 mg 6-month depot formulation (up to 24 months).
Participant milestones
| Measure |
Leuprolide Acetate - Previously Treated
Participants who had been previously treated with a GnRHa for at least 6 months prior to enrollment received leuprolide acetate (LA) 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1 and for up to an additional 96 weeks in Part 2.
|
Leuprolide Acetate - Treament Naïve
Participants without previous GnRHa treatment prior to enrollment (treatment naïve) received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1 and for up to an additional 96 weeks in Part 2.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
27
|
|
Overall Study
COMPLETED
|
8
|
20
|
|
Overall Study
NOT COMPLETED
|
10
|
7
|
Reasons for withdrawal
| Measure |
Leuprolide Acetate - Previously Treated
Participants who had been previously treated with a GnRHa for at least 6 months prior to enrollment received leuprolide acetate (LA) 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1 and for up to an additional 96 weeks in Part 2.
|
Leuprolide Acetate - Treament Naïve
Participants without previous GnRHa treatment prior to enrollment (treatment naïve) received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1 and for up to an additional 96 weeks in Part 2.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
Other, Not Specified
|
8
|
2
|
Baseline Characteristics
Reported by sex and overall
Baseline characteristics by cohort
| Measure |
Leuprolide Acetate - Previously Treated
n=18 Participants
Participants who had been previously treated with a GnRHa for at least 6 months prior to enrollment received leuprolide acetate (LA) 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
Leuprolide Acetate - Treament Naïve
n=27 Participants
Participants without previous GnRHa treatment prior to enrollment (treatment naïve) received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
8.1 years
STANDARD_DEVIATION 1.73 • n=18 Participants
|
7.7 years
STANDARD_DEVIATION 0.83 • n=27 Participants
|
7.8 years
STANDARD_DEVIATION 1.27 • n=45 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=18 Participants
|
24 Participants
n=27 Participants
|
41 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=18 Participants
|
3 Participants
n=27 Participants
|
4 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=18 Participants
|
9 Participants
n=27 Participants
|
11 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=18 Participants
|
18 Participants
n=27 Participants
|
34 Participants
n=45 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=18 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=18 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=18 Participants
|
3 Participants
n=27 Participants
|
7 Participants
n=45 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=18 Participants
|
18 Participants
n=27 Participants
|
30 Participants
n=45 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=45 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=45 Participants
|
|
Age at onset of CPP
Females
|
5.9 years
STANDARD_DEVIATION 2.37 • n=17 Participants • Reported by sex and overall
|
6.7 years
STANDARD_DEVIATION 0.99 • n=24 Participants • Reported by sex and overall
|
6.4 years
STANDARD_DEVIATION 1.74 • n=41 Participants • Reported by sex and overall
|
|
Age at onset of CPP
Males
|
2.1 years
n=1 Participants • Reported by sex and overall
|
6.9 years
STANDARD_DEVIATION 2.58 • n=3 Participants • Reported by sex and overall
|
5.7 years
STANDARD_DEVIATION 3.19 • n=4 Participants • Reported by sex and overall
|
|
Age at onset of CPP
Overall
|
5.7 years
STANDARD_DEVIATION 2.46 • n=18 Participants • Reported by sex and overall
|
6.8 years
STANDARD_DEVIATION 1.18 • n=27 Participants • Reported by sex and overall
|
6.3 years
STANDARD_DEVIATION 1.86 • n=45 Participants • Reported by sex and overall
|
PRIMARY outcome
Timeframe: Week 24 (prior to the Week 24 dose); samples for LH measurement were taken 30 and 60 minutes after the stimulation test injection.Population: The Full Analysis Set (FAS) consists of all participants who received at least 1 dose of study drug. Participants with missing GnRHa-stimulated LH results at Week 24 were counted as not achieving suppression.
Suppression of GnRHa-stimulated luteinizing hormone (LH) was measured using a peak GnRHa stimulation test, performed using subcutaneous injection with an aqueous formulation of leuprolide acetate at 20 µg/kg. Peak stimulated LH was calculated by taking the maximum LH concentrations measured from blood samples taken at 30 or 60 min following the GnRHa stimulation test. Suppression of GnRHa-stimulated luteinizing hormone is defined as peak stimulated LH less than 4 mIU/mL.
Outcome measures
| Measure |
Leuprolide Acetate - Previously Treated
n=18 Participants
Participants who had been previously treated with a GnRHa for at least 6 months prior to enrollment received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
Leuprolide Acetate - Treament Naïve
n=27 Participants
Participants without previous GnRHa treatment prior to enrollment (treatment naïve) received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
Leuprolide Acetate - Overall
n=45 Participants
Participants received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
|---|---|---|---|
|
Percentage of Participants With Suppression of Peak Gonadotropin-releasing Hormone Agonist (GnRHa)-Stimulated Luteinizing Hormone (LH) to Less Than 4 mlU/mL at Week 24
|
94.4 percentage of participants
Interval 72.7 to 99.9
|
81.5 percentage of participants
Interval 61.9 to 93.7
|
86.7 percentage of participants
Interval 73.2 to 95.0
|
SECONDARY outcome
Timeframe: Weeks 12, 20, 44, and 48 (prior to Week 48 dose); samples for LH measurement were taken 30 and 60 minutes after the stimulation test injection.Population: The Full Analysis Set (FAS) consists of all participants who received at least 1 dose of study drug. Participants with missing GnRHa-stimulated LH results at a specific visit were counted as not achieving suppression for that visit.
Suppression of GnRHa-stimulated luteinizing hormone (LH) was measured using a peak GnRHa stimulation test, performed using subcutaneous injection with an aqueous formulation of leuprolide acetate at 20 µg/kg. Peak stimulated LH was calculated by taking the maximum LH concentrations measured from blood samples taken at 30 or 60 min following the GnRHa stimulation test. Suppression of GnRHa-stimulated luteinizing hormone is defined as peak stimulated LH less than 4 mIU/mL.
Outcome measures
| Measure |
Leuprolide Acetate - Previously Treated
n=18 Participants
Participants who had been previously treated with a GnRHa for at least 6 months prior to enrollment received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
Leuprolide Acetate - Treament Naïve
n=27 Participants
Participants without previous GnRHa treatment prior to enrollment (treatment naïve) received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
Leuprolide Acetate - Overall
n=45 Participants
Participants received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
|---|---|---|---|
|
Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48
Week 12
|
83.3 percentage of participants
Interval 58.6 to 96.4
|
88.9 percentage of participants
Interval 70.8 to 97.7
|
86.7 percentage of participants
Interval 73.2 to 95.0
|
|
Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48
Week 20
|
94.4 percentage of participants
Interval 72.7 to 99.9
|
85.2 percentage of participants
Interval 66.3 to 95.8
|
88.9 percentage of participants
Interval 76.0 to 96.3
|
|
Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48
Week 44
|
88.9 percentage of participants
Interval 65.3 to 98.6
|
88.9 percentage of participants
Interval 70.8 to 97.7
|
88.9 percentage of participants
Interval 76.0 to 96.3
|
|
Part 1: Percentage of Participants With Suppression of Peak GnRHa-stimulated LH to Less Than 4 mlU/mL at Weeks 12, 20, 44, and 48
Week 48
|
83.3 percentage of participants
Interval 58.6 to 96.4
|
92.6 percentage of participants
Interval 75.7 to 99.1
|
88.9 percentage of participants
Interval 76.0 to 96.3
|
SECONDARY outcome
Timeframe: Weeks 12, 20, 24, 44, and 48Population: Full analysis set; female participants with available data at each time point
Estradiol concentrations were measured from blood samples taken at each study visit prior to stimulation testing (and prior to study drug administration at Weeks 24 and 48).
Outcome measures
| Measure |
Leuprolide Acetate - Previously Treated
n=17 Participants
Participants who had been previously treated with a GnRHa for at least 6 months prior to enrollment received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
Leuprolide Acetate - Treament Naïve
n=24 Participants
Participants without previous GnRHa treatment prior to enrollment (treatment naïve) received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
Leuprolide Acetate - Overall
n=41 Participants
Participants received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
|---|---|---|---|
|
Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48
Week 20
|
100.0 percentage of participants
Interval 79.4 to 100.0
|
95.7 percentage of participants
Interval 78.1 to 99.9
|
97.4 percentage of participants
Interval 86.5 to 99.9
|
|
Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48
Week 48
|
100.0 percentage of participants
Interval 79.4 to 100.0
|
100.0 percentage of participants
Interval 85.8 to 100.0
|
100.0 percentage of participants
Interval 91.2 to 100.0
|
|
Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48
Week 12
|
100.0 percentage of participants
Interval 79.4 to 100.0
|
95.5 percentage of participants
Interval 77.2 to 99.9
|
97.4 percentage of participants
Interval 86.2 to 99.9
|
|
Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48
Week 24
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
95.2 percentage of participants
Interval 76.2 to 99.9
|
97.4 percentage of participants
Interval 86.2 to 99.9
|
|
Part 1: Percentage of Female Participants With Suppression of Basal Estradiol to < 20 pg/mL at Weeks 12, 20, 24, 44, and 48
Week 44
|
100.0 percentage of participants
Interval 80.5 to 100.0
|
100.0 percentage of participants
Interval 85.2 to 100.0
|
100.0 percentage of participants
Interval 91.2 to 100.0
|
SECONDARY outcome
Timeframe: Weeks 12, 20, 24, 44, and 48Population: Full analysis set; male participants with available data at each time point
Testosterone concentrations were measured from blood samples taken at each study visit prior to stimulation testing (and prior to study drug administration for Weeks 24 and 48).
Outcome measures
| Measure |
Leuprolide Acetate - Previously Treated
n=1 Participants
Participants who had been previously treated with a GnRHa for at least 6 months prior to enrollment received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
Leuprolide Acetate - Treament Naïve
n=3 Participants
Participants without previous GnRHa treatment prior to enrollment (treatment naïve) received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
Leuprolide Acetate - Overall
n=4 Participants
Participants received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
|---|---|---|---|
|
Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48
Week 12
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
|
Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48
Week 24
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
|
Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48
Week 44
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
|
Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48
Week 20
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
|
Part 1: Percentage of Male Participants With Suppression of Basal Testosterone to < 30 ng/dL at Weeks 12, 20, 24, 44, and 48
Week 48
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
SECONDARY outcome
Timeframe: Part 1: Weeks 24 and 48; Part 2: Weeks 72, 96, 120, and 144Population: Full analysis set; results for males and females (with an assessment at each time point) are reported separately.
Breast development in females and testicular volume or genital development in males was assessed using modified Tanner staging, on a scale from Stage 1 (prepubertal) to Stage 5 (adult characteristics). Females: Suppression is defined as regression or no progression of breast development according to modified Tanner staging. Males: Suppression is defined as regression or no progression in testicular volume and genital staging according to modified Tanner staging.
Outcome measures
| Measure |
Leuprolide Acetate - Previously Treated
n=18 Participants
Participants who had been previously treated with a GnRHa for at least 6 months prior to enrollment received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
Leuprolide Acetate - Treament Naïve
n=27 Participants
Participants without previous GnRHa treatment prior to enrollment (treatment naïve) received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
Leuprolide Acetate - Overall
n=45 Participants
Participants received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
|---|---|---|---|
|
Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty
Females: Week 24
|
94.1 percentage of participants
|
91.7 percentage of participants
|
92.7 percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty
Females: Week 48
|
88.2 percentage of participants
|
91.7 percentage of participants
|
90.2 percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty
Females: Week 72
|
93.8 percentage of participants
|
95.7 percentage of participants
|
94.9 percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty
Females: Week 96
|
100 percentage of participants
|
90.5 percentage of participants
|
94.3 percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty
Females: Week 120
|
91.7 percentage of participants
|
89.5 percentage of participants
|
90.3 percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty
Females: Week 144
|
83.3 percentage of participants
|
87.5 percentage of participants
|
86.4 percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty
Males: Week 24
|
0 percentage of participants
|
66.7 percentage of participants
|
50.0 percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty
Males: Week 48
|
100 percentage of participants
|
66.7 percentage of participants
|
75.0 percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty
Males: Week 72
|
0 percentage of participants
|
66.7 percentage of participants
|
50.0 percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty
Males: Week 96
|
100 percentage of participants
|
66.7 percentage of participants
|
75.0 percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty
Males: Week 120
|
0 percentage of participants
|
66.7 percentage of participants
|
50.0 percentage of participants
|
|
Parts 1 and 2: Percentage of Participants With Suppression of the Physical Signs of Puberty
Males: Week 144
|
0 percentage of participants
|
100 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Part 1: Baseline and Weeks 4, 12, 20, 24, 44, and 48; Part 2: Weeks 72, 96, 120, and 144Population: Full analysis set; participants with available data at Baseline (43 participants) and each time point.
Growth rate (height in centimeter/year) was calculated both prior to treatment in the study and during the study. For Baseline calculation a historical measurement of height at least 6 months prior to Screening and the Screening value was used.
Outcome measures
| Measure |
Leuprolide Acetate - Previously Treated
n=17 Participants
Participants who had been previously treated with a GnRHa for at least 6 months prior to enrollment received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
Leuprolide Acetate - Treament Naïve
n=26 Participants
Participants without previous GnRHa treatment prior to enrollment (treatment naïve) received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
Leuprolide Acetate - Overall
n=43 Participants
Participants received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
|---|---|---|---|
|
Parts 1 and 2: Change From Baseline in Incremental Growth Rate
Week 24
|
-0.5 cm/year
Standard Deviation 2.81
|
-3.7 cm/year
Standard Deviation 4.28
|
-2.4 cm/year
Standard Deviation 4.03
|
|
Parts 1 and 2: Change From Baseline in Incremental Growth Rate
Week 72
|
-0.5 cm/year
Standard Deviation 2.09
|
-4.3 cm/year
Standard Deviation 3.53
|
-2.8 cm/year
Standard Deviation 3.55
|
|
Parts 1 and 2: Change From Baseline in Incremental Growth Rate
Week 96
|
-0.6 cm/year
Standard Deviation 2.29
|
-4.9 cm/year
Standard Deviation 3.43
|
-3.2 cm/year
Standard Deviation 3.68
|
|
Parts 1 and 2: Change From Baseline in Incremental Growth Rate
Week 4
|
-0.6 cm/year
Standard Deviation 9.99
|
-0.9 cm/year
Standard Deviation 10.52
|
-0.8 cm/year
Standard Deviation 10.19
|
|
Parts 1 and 2: Change From Baseline in Incremental Growth Rate
Week 12
|
-0.6 cm/year
Standard Deviation 4.09
|
-2.9 cm/year
Standard Deviation 5.42
|
-2.0 cm/year
Standard Deviation 5.02
|
|
Parts 1 and 2: Change From Baseline in Incremental Growth Rate
Week 20
|
-0.5 cm/year
Standard Deviation 2.61
|
-3.8 cm/year
Standard Deviation 4.69
|
-2.5 cm/year
Standard Deviation 4.28
|
|
Parts 1 and 2: Change From Baseline in Incremental Growth Rate
Week 44
|
-0.4 cm/year
Standard Deviation 2.48
|
-4.1 cm/year
Standard Deviation 3.77
|
-2.6 cm/year
Standard Deviation 3.76
|
|
Parts 1 and 2: Change From Baseline in Incremental Growth Rate
Week 48
|
-0.3 cm/year
Standard Deviation 2.67
|
-3.5 cm/year
Standard Deviation 4.71
|
-2.3 cm/year
Standard Deviation 4.32
|
|
Parts 1 and 2: Change From Baseline in Incremental Growth Rate
Week 120
|
-1.2 cm/year
Standard Deviation 1.96
|
-5.6 cm/year
Standard Deviation 3.27
|
-3.9 cm/year
Standard Deviation 3.54
|
|
Parts 1 and 2: Change From Baseline in Incremental Growth Rate
Week 144
|
-1.0 cm/year
Standard Deviation 1.63
|
-5.3 cm/year
Standard Deviation 2.76
|
-4.0 cm/year
Standard Deviation 3.19
|
SECONDARY outcome
Timeframe: Part 1: Baseline and Weeks 24 and 48; Part 2: Weeks 72, 96, 120, and 144Population: Full analysis set; based on non missing observations.
Bone age was assessed from radiographs of the hand and wrist by a central imaging vendor using the BoneXpert automated system. A ratio less than 1 indicates less advancement of bone age compared to chronological age.
Outcome measures
| Measure |
Leuprolide Acetate - Previously Treated
n=18 Participants
Participants who had been previously treated with a GnRHa for at least 6 months prior to enrollment received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
Leuprolide Acetate - Treament Naïve
n=27 Participants
Participants without previous GnRHa treatment prior to enrollment (treatment naïve) received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
Leuprolide Acetate - Overall
n=45 Participants
Participants received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
|---|---|---|---|
|
Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age
Week 24
|
0.5 ratio
Standard Deviation 0.80
|
0.7 ratio
Standard Deviation 0.56
|
0.6 ratio
Standard Deviation 0.66
|
|
Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age
Week 48
|
0.2 ratio
Standard Deviation 1.36
|
0.6 ratio
Standard Deviation 0.41
|
0.5 ratio
Standard Deviation 0.93
|
|
Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age
Week 72
|
0.6 ratio
Standard Deviation 0.31
|
0.6 ratio
Standard Deviation 0.38
|
0.6 ratio
Standard Deviation 0.35
|
|
Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age
Week 96
|
0.6 ratio
Standard Deviation 0.32
|
0.7 ratio
Standard Deviation 0.28
|
0.6 ratio
Standard Deviation 0.29
|
|
Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age
Week 120
|
0.5 ratio
Standard Deviation 0.28
|
0.6 ratio
Standard Deviation 0.34
|
0.6 ratio
Standard Deviation 0.32
|
|
Parts 1 and 2: Ratio of Change From Baseline in Bone Age to Change From Baseline in Chronological Age
Week 144
|
0.6 ratio
Standard Deviation 0.26
|
0.6 ratio
Standard Deviation 0.24
|
0.6 ratio
Standard Deviation 0.24
|
SECONDARY outcome
Timeframe: Weeks 72, 96, 120, and 144Population: Full analysis set; observed cases.
Suppression of GnRHa-stimulated luteinizing hormone (LH) was measured using a peak GnRHa stimulation test, performed using subcutaneous injection with an aqueous formulation of leuprolide acetate at 20 µg/kg. Peak stimulated LH was calculated by taking the maximum LH concentrations measured from blood samples taken at 30 or 60 min following the GnRHa stimulation test. Suppression of GnRHa-stimulated luteinizing hormone is defined as peak stimulated LH less than 4 mIU/mL.
Outcome measures
| Measure |
Leuprolide Acetate - Previously Treated
n=17 Participants
Participants who had been previously treated with a GnRHa for at least 6 months prior to enrollment received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
Leuprolide Acetate - Treament Naïve
n=26 Participants
Participants without previous GnRHa treatment prior to enrollment (treatment naïve) received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
Leuprolide Acetate - Overall
n=43 Participants
Participants received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
|---|---|---|---|
|
Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL)
Week 72
|
88.2 percentage of participants
Interval 63.6 to 98.5
|
96.2 percentage of participants
Interval 80.4 to 99.9
|
93.0 percentage of participants
Interval 80.9 to 98.5
|
|
Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL)
Week 96
|
93.3 percentage of participants
Interval 68.1 to 99.8
|
95.7 percentage of participants
Interval 78.1 to 99.9
|
94.7 percentage of participants
Interval 82.3 to 99.4
|
|
Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL)
Week 120
|
100.0 percentage of participants
Interval 75.3 to 100.0
|
100.0 percentage of participants
Interval 84.6 to 100.0
|
100.0 percentage of participants
Interval 90.0 to 100.0
|
|
Part 2: Percentage of Participants With Maintenance of Suppression of GnRHa-stimulated LH (< 4 mlU/mL)
Week 144
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
100.0 percentage of participants
Interval 79.4 to 100.0
|
100.0 percentage of participants
Interval 85.2 to 100.0
|
SECONDARY outcome
Timeframe: Weeks 72, 96, 120, and 144Population: Full analysis set; participants with non-missing observations.
Estradiol concentrations were measured from blood samples taken at each study visit prior to stimulation testing.
Outcome measures
| Measure |
Leuprolide Acetate - Previously Treated
n=16 Participants
Participants who had been previously treated with a GnRHa for at least 6 months prior to enrollment received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
Leuprolide Acetate - Treament Naïve
n=23 Participants
Participants without previous GnRHa treatment prior to enrollment (treatment naïve) received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
Leuprolide Acetate - Overall
n=39 Participants
Participants received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
|---|---|---|---|
|
Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL
Week 96
|
100.0 percentage of participants
Interval 76.8 to 100.0
|
100.0 percentage of participants
Interval 83.2 to 100.0
|
100.0 percentage of participants
Interval 89.7 to 100.0
|
|
Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL
Week 120
|
100.0 percentage of participants
Interval 71.5 to 100.0
|
100.0 percentage of participants
Interval 82.4 to 100.0
|
100.0 percentage of participants
Interval 88.4 to 100.0
|
|
Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL
Week 72
|
100.0 percentage of participants
Interval 79.4 to 100.0
|
100.0 percentage of participants
Interval 85.2 to 100.0
|
100.0 percentage of participants
Interval 91.0 to 100.0
|
|
Part 2: Percentage of Female Participants With Maintenance of Suppression of Basal Estradiol to < 20 pg/mL
Week 144
|
100.0 percentage of participants
Interval 54.1 to 100.0
|
100.0 percentage of participants
Interval 78.2 to 100.0
|
100.0 percentage of participants
Interval 83.9 to 100.0
|
SECONDARY outcome
Timeframe: Weeks 72, 96, 120, and 144Population: Full analysis set; participants with non-missing observations.
Male participants with maintenance of suppression of testosterone to \< 30 ng/dL are assessed
Outcome measures
| Measure |
Leuprolide Acetate - Previously Treated
n=1 Participants
Participants who had been previously treated with a GnRHa for at least 6 months prior to enrollment received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
Leuprolide Acetate - Treament Naïve
n=3 Participants
Participants without previous GnRHa treatment prior to enrollment (treatment naïve) received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
Leuprolide Acetate - Overall
n=4 Participants
Participants received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1.
|
|---|---|---|---|
|
Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL
Week 72
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
|
Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL
Week 96
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
|
Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL
Week 120
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 29.2 to 100.0
|
100.0 percentage of participants
Interval 39.8 to 100.0
|
|
Part 2: Percentage of Male Participants With Maintenance of Suppression of Basal Testosterone to < 30 ng/dL
Week 144
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
Adverse Events
Leuprolide Acetate - Previously Treated
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Leuprolide Acetate - Treament Naïve
Serious events: 1 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Leuprolide Acetate - Previously Treated
n=18 participants at risk
Participants who had been previously treated with a GnRHa for at least 6 months prior to enrollment received leuprolide acetate (LA) 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1 and for up to an additional 96 weeks in Part 2.
|
Leuprolide Acetate - Treament Naïve
n=27 participants at risk
Participants without previous GnRHa treatment prior to enrollment (treatment naïve) received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1 and for up to an additional 96 weeks in Part 2.
|
|---|---|---|
|
Psychiatric disorders
AFFECTIVE DISORDER
|
0.00%
0/18 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
3.7%
1/27 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
Other adverse events
| Measure |
Leuprolide Acetate - Previously Treated
n=18 participants at risk
Participants who had been previously treated with a GnRHa for at least 6 months prior to enrollment received leuprolide acetate (LA) 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1 and for up to an additional 96 weeks in Part 2.
|
Leuprolide Acetate - Treament Naïve
n=27 participants at risk
Participants without previous GnRHa treatment prior to enrollment (treatment naïve) received leuprolide acetate 45 mg every 6 months administered as an intramuscular injection for up to 48 weeks in Part 1 and for up to an additional 96 weeks in Part 2.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Blood and lymphatic system disorders
IRON DEFICIENCY ANAEMIA
|
0.00%
0/18 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
7.4%
2/27 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Blood and lymphatic system disorders
LYMPHADENOPATHY
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Ear and labyrinth disorders
EAR PAIN
|
11.1%
2/18 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
3.7%
1/27 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Eye disorders
EYE PAIN
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
3.7%
1/27 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Eye disorders
PHOTOPSIA
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
11.1%
3/27 • Number of events 4 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN LOWER
|
11.1%
2/18 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
22.2%
6/27 • Number of events 6 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Gastrointestinal disorders
CONSTIPATION
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
3.7%
1/27 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Gastrointestinal disorders
DIARRHOEA
|
5.6%
1/18 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
11.1%
3/27 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Gastrointestinal disorders
LIP BLISTER
|
5.6%
1/18 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Gastrointestinal disorders
NAUSEA
|
11.1%
2/18 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
11.1%
3/27 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Gastrointestinal disorders
ORAL PAIN
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Gastrointestinal disorders
TOOTH IMPACTED
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Gastrointestinal disorders
TOOTHACHE
|
0.00%
0/18 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
7.4%
2/27 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Gastrointestinal disorders
VOMITING
|
16.7%
3/18 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
11.1%
3/27 • Number of events 5 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
General disorders
CHEST PAIN
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
3.7%
1/27 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
General disorders
CRYING
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
14.8%
4/27 • Number of events 4 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
General disorders
FATIGUE
|
16.7%
3/18 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
General disorders
FEELING HOT
|
11.1%
2/18 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
3.7%
1/27 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
General disorders
GAIT DISTURBANCE
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
7.4%
2/27 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
General disorders
INJECTED LIMB MOBILITY DECREASED
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
General disorders
INJECTION SITE BRUISING
|
11.1%
2/18 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
General disorders
INJECTION SITE DISCOMFORT
|
5.6%
1/18 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
General disorders
INJECTION SITE ERYTHEMA
|
16.7%
3/18 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
14.8%
4/27 • Number of events 4 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
General disorders
INJECTION SITE PAIN
|
88.9%
16/18 • Number of events 39 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
96.3%
26/27 • Number of events 94 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
General disorders
INJECTION SITE PRURITUS
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
General disorders
INJECTION SITE REACTION
|
22.2%
4/18 • Number of events 6 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
33.3%
9/27 • Number of events 18 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
General disorders
INJECTION SITE SWELLING
|
16.7%
3/18 • Number of events 5 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
3.7%
1/27 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
General disorders
INJECTION SITE WARMTH
|
16.7%
3/18 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
11.1%
3/27 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
General disorders
MALAISE
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
General disorders
MEDICAL DEVICE PAIN
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
General disorders
PAIN
|
27.8%
5/18 • Number of events 9 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
18.5%
5/27 • Number of events 7 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
General disorders
PYREXIA
|
33.3%
6/18 • Number of events 6 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
18.5%
5/27 • Number of events 6 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
General disorders
SWELLING
|
5.6%
1/18 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
7.4%
2/27 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
General disorders
TENDERNESS
|
11.1%
2/18 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
3.7%
1/27 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Immune system disorders
MULTIPLE ALLERGIES
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
7.4%
2/27 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Immune system disorders
SEASONAL ALLERGY
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
7.4%
2/27 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Infections and infestations
COVID-19
|
16.7%
3/18 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
33.3%
9/27 • Number of events 10 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Infections and infestations
GASTROENTERITIS
|
16.7%
3/18 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
7.4%
2/27 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
3.7%
1/27 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Infections and infestations
INFLUENZA
|
22.2%
4/18 • Number of events 5 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
11.1%
3/27 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Infections and infestations
LICE INFESTATION
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Infections and infestations
NASOPHARYNGITIS
|
22.2%
4/18 • Number of events 6 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
11.1%
3/27 • Number of events 7 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Infections and infestations
OTITIS EXTERNA
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Infections and infestations
PHARYNGITIS STREPTOCOCCAL
|
11.1%
2/18 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
14.8%
4/27 • Number of events 6 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Infections and infestations
SINUSITIS
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
11.1%
3/27 • Number of events 4 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Infections and infestations
TINEA VERSICOLOUR
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
3.7%
1/27 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
27.8%
5/18 • Number of events 5 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
25.9%
7/27 • Number of events 8 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/18 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
7.4%
2/27 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
11.1%
2/18 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Injury, poisoning and procedural complications
FALL
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Injury, poisoning and procedural complications
FOOT FRACTURE
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Injury, poisoning and procedural complications
FRACTURED COCCYX
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Injury, poisoning and procedural complications
HUMAN BITE
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Injury, poisoning and procedural complications
LIGAMENT SPRAIN
|
16.7%
3/18 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
7.4%
2/27 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Injury, poisoning and procedural complications
MUSCLE STRAIN
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
3.7%
1/27 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Injury, poisoning and procedural complications
NAIL INJURY
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Injury, poisoning and procedural complications
TIBIA FRACTURE
|
16.7%
3/18 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Investigations
WEIGHT INCREASED
|
11.1%
2/18 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Metabolism and nutrition disorders
ABNORMAL WEIGHT GAIN
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
7.4%
2/27 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Metabolism and nutrition disorders
IRON DEFICIENCY
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.00%
0/18 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
7.4%
2/27 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
16.7%
3/18 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
3.7%
1/27 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Musculoskeletal and connective tissue disorders
JOINT RANGE OF MOTION DECREASED
|
0.00%
0/18 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
7.4%
2/27 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Musculoskeletal and connective tissue disorders
KNEE DEFORMITY
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
11.1%
3/27 • Number of events 4 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
14.8%
4/27 • Number of events 4 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Nervous system disorders
CLUSTER HEADACHE
|
5.6%
1/18 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Nervous system disorders
DIZZINESS
|
0.00%
0/18 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
7.4%
2/27 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Nervous system disorders
HEADACHE
|
50.0%
9/18 • Number of events 14 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
33.3%
9/27 • Number of events 20 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Psychiatric disorders
AFFECTIVE DISORDER
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Psychiatric disorders
AGGRESSION
|
0.00%
0/18 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
7.4%
2/27 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Psychiatric disorders
ANGER
|
0.00%
0/18 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
11.1%
3/27 • Number of events 5 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Psychiatric disorders
ANXIETY
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
3.7%
1/27 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Psychiatric disorders
ATTENTION DEFICIT HYPERACTIVITY DISORDER
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
3.7%
1/27 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Psychiatric disorders
DEPRESSED MOOD
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Psychiatric disorders
EMOTIONAL DISORDER
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
18.5%
5/27 • Number of events 7 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Psychiatric disorders
HALLUCINATION, AUDITORY
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Psychiatric disorders
INITIAL INSOMNIA
|
0.00%
0/18 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
7.4%
2/27 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Psychiatric disorders
INSOMNIA
|
11.1%
2/18 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
3.7%
1/27 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Psychiatric disorders
IRRITABILITY
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
7.4%
2/27 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Psychiatric disorders
MOOD ALTERED
|
5.6%
1/18 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
18.5%
5/27 • Number of events 7 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Psychiatric disorders
MOOD SWINGS
|
0.00%
0/18 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
7.4%
2/27 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Psychiatric disorders
TEARFULNESS
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Reproductive system and breast disorders
BREAST PAIN
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
3.7%
1/27 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Reproductive system and breast disorders
BREAST TENDERNESS
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
3.7%
1/27 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Reproductive system and breast disorders
NIPPLE PAIN
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Reproductive system and breast disorders
VAGINAL DISCHARGE
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
3.7%
1/27 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
3.7%
1/27 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Reproductive system and breast disorders
VULVOVAGINAL DISCOMFORT
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Reproductive system and breast disorders
VULVOVAGINAL PRURITUS
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
3.7%
1/27 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
16.7%
3/18 • Number of events 5 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
22.2%
6/27 • Number of events 7 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/18 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
7.4%
2/27 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
11.1%
2/18 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
7.4%
2/27 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
27.8%
5/18 • Number of events 6 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
11.1%
3/27 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
11.1%
2/18 • Number of events 4 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
11.1%
3/27 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
SINUS CONGESTION
|
0.00%
0/18 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
7.4%
2/27 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
SNEEZING
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
7.4%
2/27 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/18 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
7.4%
2/27 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/18 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
11.1%
3/27 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Skin and subcutaneous tissue disorders
RASH
|
11.1%
2/18 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
11.1%
3/27 • Number of events 3 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Skin and subcutaneous tissue disorders
SKIN ODOUR ABNORMAL
|
0.00%
0/18 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
7.4%
2/27 • Number of events 2 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
|
Vascular disorders
HOT FLUSH
|
5.6%
1/18 • Number of events 1 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
0.00%
0/27 • From screening through end of study; median 949.5 and 1092.0 days for previously-treated and treatment-naïve participants, respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER