Trial Outcomes & Findings for A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty (NCT NCT00635817)

NCT ID: NCT00635817

Last Updated: 2011-11-02

Results Overview

Percentage of participants with suppression of peak stimulated luteinizing hormone that was measured after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test at Month (Mo) 2, 3, and 6. The analysis was performed according to a life table method. Subjects who withdrew without peak-stimulated luteinizing hormone \>= 4 mIU/mL were censored at their last measurement of peak-stimulated luteinizing hormone.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 84 participants
• Primary outcome timeframe: Month 2 through 6
• Results posted on: 2011-11-02

Participant Flow

Eighteen sites in the US and 4 sites in Puerto Rico enrolled subjects into the study. The first subject was randomized 17 June 2008 and the last subject was randomized 12 Aug 2009.

Subjects were randomized in a 1:1 ratio to 1 of the 2 treatment arms. To ensure balanced randomization, the study drug assignment was stratified on the basis of whether subjects were treatment-naive or had been treated with GnRHa previously.

Participant milestones

Measure	Leuprolide Acetate 11.25 mg - Treatment Naive Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 11.25 mg - Previous Treatment Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Treatment Naive Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Previous Treatment Subjects who received at least 1 dose of study drug.
Overall Study STARTED	21	21	21	21
Overall Study COMPLETED	15	19	19	21
Overall Study NOT COMPLETED	6	2	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Leuprolide 11.25 mg and 30 mg Administered Every 3 Months to Treat Central Precocious Puberty

Baseline characteristics by cohort

Measure	Leuprolide Acetate 11.25 mg - Treatment Naive n=21 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 11.25 mg - Previous Treatment n=21 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Treatment Naive n=21 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Previous Treatment n=21 Participants Subjects who received at least 1 dose of study drug.	Total n=84 Participants Total of all reporting groups
Age, Categorical <=18 years	21 Participants n=5 Participants	21 Participants n=7 Participants	21 Participants n=5 Participants	21 Participants n=4 Participants	84 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age Continuous	7.4 Years STANDARD_DEVIATION 1.47 • n=5 Participants	8.1 Years STANDARD_DEVIATION 1.83 • n=7 Participants	7.3 Years STANDARD_DEVIATION 1.74 • n=5 Participants	8.4 Years STANDARD_DEVIATION 1.75 • n=4 Participants	7.8 Years STANDARD_DEVIATION 1.73 • n=21 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	20 Participants n=7 Participants	19 Participants n=5 Participants	18 Participants n=4 Participants	76 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	8 Participants n=21 Participants
Region of Enrollment North America	21 Participants n=5 Participants	21 Participants n=7 Participants	21 Participants n=5 Participants	21 Participants n=4 Participants	84 Participants n=21 Participants

PRIMARY outcome

Timeframe: Month 2 through 6

Population: Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement of peak stimulated luteinizing hormone at Mo 2 or afterward defined as the intent-to-treat population.

Percentage of participants with suppression of peak stimulated luteinizing hormone that was measured after a gonadotropin-releasing hormone agonist (GnRHa) stimulation test at Month (Mo) 2, 3, and 6. The analysis was performed according to a life table method. Subjects who withdrew without peak-stimulated luteinizing hormone >= 4 mIU/mL were censored at their last measurement of peak-stimulated luteinizing hormone.

Outcome measures

Measure	Leuprolide Acetate 11.25 mg - Treatment Naive n=21 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 11.25 mg - Previous Treatment n=21 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Treatment Naive n=21 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Previous Treatment n=21 Participants Subjects who received at least 1 dose of study drug.
Percentage of Participants With Suppression of Peak Stimulated Luteinizing Hormone (<4 mIU/mL) From Month 2 Through Month 6	76.2 Percentage of Participants 95% Confidence Interval 9.29 • Interval 58.0 to 94.4	80.7 Percentage of Participants 95% Confidence Interval 8.69 • Interval 63.6 to 97.7	90.5 Percentage of Participants 95% Confidence Interval 6.41 • Interval 77.9 to 100.0	100 Percentage of Participants 95% Confidence Interval 0.00 • Interval 100.0 to 100.0

SECONDARY outcome

Timeframe: Month 1, 2, 3 and 6

Population: Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.

Percentage of participants with suppression of estradiol, out of the number of girls with at least 1 estradiol measurement at each visit (n/N%). Only girls are analyzed in this outcome measure. Observed data were used with no imputation for missing data.

Outcome measures

Measure	Leuprolide Acetate 11.25 mg - Treatment Naive n=19 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 11.25 mg - Previous Treatment n=20 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Treatment Naive n=19 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Previous Treatment n=18 Participants Subjects who received at least 1 dose of study drug.
Percentage of Participants With Suppression of Basal Estradiol <20 pg/mL by Visit Mo 1 (Arm A N=17, B N=18, C N=19, D N=16)	100 Percentage of Participants Interval 80.5 to 100.0	100 Percentage of Participants Interval 81.5 to 100.0	100 Percentage of Participants Interval 82.4 to 100.0	100 Percentage of Participants Interval 79.4 to 100.0
Percentage of Participants With Suppression of Basal Estradiol <20 pg/mL by Visit Mo 2 (Arm A N=19, B N=14, C N=19, D N=14)	94.7 Percentage of Participants Interval 74.0 to 99.9	100 Percentage of Participants Interval 76.8 to 100.0	100 Percentage of Participants Interval 82.4 to 100.0	100 Percentage of Participants Interval 76.8 to 100.0
Percentage of Participants With Suppression of Basal Estradiol <20 pg/mL by Visit Mo 3 (Arm A N=15, B N=18, C N=17, D N=18)	100 Percentage of Participants Interval 78.2 to 100.0	100 Percentage of Participants Interval 81.5 to 100.0	100 Percentage of Participants Interval 80.5 to 100.0	100 Percentage of Participants Interval 81.5 to 100.0
Percentage of Participants With Suppression of Basal Estradiol <20 pg/mL by Visit Mo 6 (Arm A N=12, B N=16, C N=15, D N=17)	100 Percentage of Participants Interval 73.5 to 100.0	93.8 Percentage of Participants Interval 69.8 to 99.8	100 Percentage of Participants Interval 78.2 to 100.0	100 Percentage of Participants Interval 80.5 to 100.0

SECONDARY outcome

Timeframe: Month 1, 2, 3 and 6

Population: Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.

Percentage of participants with suppression of testosterone, out of the number of boys with at least 1 testosterone measurement at each visit (n/N%). Only boys are analyzed in this outcome measure. Observed data were used with no imputation for missing data.

Outcome measures

Measure	Leuprolide Acetate 11.25 mg - Treatment Naive n=2 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 11.25 mg - Previous Treatment n=1 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Treatment Naive n=2 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Previous Treatment n=3 Participants Subjects who received at least 1 dose of study drug.
Percentage of Participants With Suppression of Testosterone in <30 ng/dL by Visit Mo 1 (Arm A N=2, B N=1, C N=2, D N=3)	50.0 Percentage of Participants Interval 1.3 to 98.7	100 Percentage of Participants Interval 2.5 to 100.0	100 Percentage of Participants Interval 15.8 to 100.0	100 Percentage of Participants Interval 29.2 to 100.0
Percentage of Participants With Suppression of Testosterone in <30 ng/dL by Visit Mo 2 (Arm A N=2, B N=1, C N=2, D N=3)	50.0 Percentage of Participants Interval 1.3 to 98.7	100 Percentage of Participants Interval 2.5 to 100.0	100 Percentage of Participants Interval 15.8 to 100.0	100 Percentage of Participants Interval 29.2 to 100.0
Percentage of Participants With Suppression of Testosterone in <30 ng/dL by Visit Mo 3 (Arm A N=2, B N=1, C N=2, D N=3)	50.0 Percentage of Participants Interval 1.3 to 98.7	100 Percentage of Participants Interval 2.5 to 100.0	100 Percentage of Participants Interval 15.8 to 100.0	100 Percentage of Participants Interval 29.2 to 100.0
Percentage of Participants With Suppression of Testosterone in <30 ng/dL by Visit Mo 6 (Arm A N=1, B N=1, C N=2, D N=3)	100 Percentage of Participants Interval 2.5 to 100.0	100 Percentage of Participants Interval 2.5 to 100.0	100 Percentage of Participants Interval 15.8 to 100.0	100 Percentage of Participants Interval 29.2 to 100.0

SECONDARY outcome

Timeframe: Baseline, Month 1, 2, 3 and 6

Population: Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.

Observed data were used with no imputation for missing data.

Outcome measures

Measure	Leuprolide Acetate 11.25 mg - Treatment Naive n=21 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 11.25 mg - Previous Treatment n=21 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Treatment Naive n=21 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Previous Treatment n=21 Participants Subjects who received at least 1 dose of study drug.
Peak-stimulated Luteinizing Hormone Concentration by Visit Baseline (Arm A N=21, B N=21, C N=21, D N=21)	45.9 mIU/mL Standard Deviation 42.38	1.8 mIU/mL Standard Deviation 1.78	23.5 mIU/mL Standard Deviation 16.76	1.7 mIU/mL Standard Deviation 1.09
Peak-stimulated Luteinizing Hormone Concentration by Visit Mo 1 (Arm A N=21, B N=21, C N=21, D N=21)	4.4 mIU/mL Standard Deviation 7.29	1.7 mIU/mL Standard Deviation 1.36	1.9 mIU/mL Standard Deviation 1.74	1.4 mIU/mL Standard Deviation 0.76
Peak-stimulated Luteinizing Hormone Concentration by Visit Mo 2 (Arm A N=21, B N=20, C N=21, D N=20)	4.5 mIU/mL Standard Deviation 7.20	2.0 mIU/mL Standard Deviation 1.48	2.0 mIU/mL Standard Deviation 2.25	1.5 mIU/mL Standard Deviation 0.73
Peak-stimulated Luteinizing Hormone Concentration by Visit Mo 3 (Arm A N=16, B N=20, C N=20, D N=21)	2.3 mIU/mL Standard Deviation 1.23	1.8 mIU/mL Standard Deviation 1.10	1.4 mIU/mL Standard Deviation 0.78	1.5 mIU/mL Standard Deviation 0.61
Peak-stimulated Luteinizing Hormone Concentration by Visit Mo 6 (Arm A N=15, B N=18, C N=18, D N=21)	2.0 mIU/mL Standard Deviation 0.85	2.5 mIU/mL Standard Deviation 2.43	1.6 mIU/mL Standard Deviation 0.95	1.5 mIU/mL Standard Deviation 0.89

SECONDARY outcome

Timeframe: Month 6

Population: Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.

Percentage of participants with suppression of breast development, out of the number of girls with pubertal staging of breast development (n/N%). Only girls are analyzed in this outcome measure. Breast development was rated from Stage 1 (early development) through Stage 5 (full development) according to a Tanner Staging pictogram. Girls entering the study with fully developed breasts (Stage 5) were excluded from this analysis. Observed data were used with no imputation for missing data.

Outcome measures

Measure	Leuprolide Acetate 11.25 mg - Treatment Naive n=14 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 11.25 mg - Previous Treatment n=18 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Treatment Naive n=17 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Previous Treatment n=17 Participants Subjects who received at least 1 dose of study drug.
Percentage of Participants With Suppression of the Physical Signs of Puberty (Breast Development) at Month 6	92.9 Percentage of Participants Interval 66.1 to 99.8	88.9 Percentage of Participants Interval 65.3 to 98.6	82.4 Percentage of Participants Interval 56.6 to 96.2	82.4 Percentage of Participants Interval 56.6 to 96.2

SECONDARY outcome

Timeframe: Month 6

Population: Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.

Percentage of participants with suppression of genital development and testicular volume, out of the number of boys with pubertal staging of genital development or testicular volume (n/N%). Only boys are analyzed in this outcome measure. External genital development (testes and penis) was rated from Stage 1 (early development) through Stage 5 (full development) according to a Tanner Staging pictogram. Boys entering the study with fully developed genitals (Stage 5) were excluded from this analysis. Observed data were used with no imputation for missing data.

Outcome measures

Measure	Leuprolide Acetate 11.25 mg - Treatment Naive n=1 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 11.25 mg - Previous Treatment n=1 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Treatment Naive n=2 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Previous Treatment n=3 Participants Subjects who received at least 1 dose of study drug.
Percentage of Participants With Suppression of the Physical Signs of Puberty (Testicular Volume and Genital Development) at Month 6	100 Percentage of Participants Interval 2.5 to 100.0	0 Percentage of Participants Interval 0.0 to 97.5	50 Percentage of Participants Interval 1.3 to 98.7	33.3 Percentage of Participants Interval 0.8 to 90.6

SECONDARY outcome

Timeframe: Baseline and Month 6

Population: Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.

The growth rate at baseline was the growth rate during the last year before the start of treatment and was calculated with the measurement closest to Day -336 (before Day -30) and the measurement up to Day 1. Growth rate at Month 6 was defined as the ratio of the change in height from Day 1 to the change in chronological age, with an approximate 6-month interval between the 2 height measurements. Observed data were used with no imputation for missing data.

Outcome measures

Measure	Leuprolide Acetate 11.25 mg - Treatment Naive n=20 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 11.25 mg - Previous Treatment n=21 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Treatment Naive n=21 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Previous Treatment n=21 Participants Subjects who received at least 1 dose of study drug.
Change From Baseline in Incremental Growth Rate (cm/Year) at Month 6 Baseline (Arm A N=20, B N=21, C N=21, D N=21)	7.25 cm/year Standard Deviation 5.30	6.58 cm/year Standard Deviation 2.39	7.83 cm/year Standard Deviation 5.96	6.05 cm/year Standard Deviation 1.55
Change From Baseline in Incremental Growth Rate (cm/Year) at Month 6 Mo 6 (Arm A N=14, B N=19, C N=19, D N=21)	-2.51 cm/year Standard Deviation 5.29	-0.98 cm/year Standard Deviation 2.24	-2.34 cm/year Standard Deviation 4.22	-0.91 cm/year Standard Deviation 2.45

SECONDARY outcome

Timeframe: Baseline to Month 6

Population: Participants must have received at least 1 dose of study drug and had at least 1 postbaseline measurement defined as the intent-to-treat population.

The ratio at Month 6 was calculated as (bone age at Month 6 - bone age at baseline)/(chronological age at Month 6 - chronological age at baseline). Observed data were used with no imputation for missing data. Baseline bone-age radiograph was performed at or within 3 months of the Screening Visit.

Outcome measures

Measure	Leuprolide Acetate 11.25 mg - Treatment Naive n=15 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 11.25 mg - Previous Treatment n=18 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Treatment Naive n=18 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Previous Treatment n=21 Participants Subjects who received at least 1 dose of study drug.
Ratio of Change From Baseline in Bone Age/Change From Baseline in Chronological Age at Month 6	0.59 Ratio Standard Deviation 0.59	0.50 Ratio Standard Deviation 0.57	1.00 Ratio Standard Deviation 0.74	1.07 Ratio Standard Deviation 1.60

POST_HOC outcome

Timeframe: Month 2 through 6

Population: Subjects must have received at least 1 dose of study drug and had at least 1 postbaseline measurement of peak stimulated luteinizing hormone at Mo 2 or afterward defined as the intent-to-treat population.

Percentage of participants with suppression of peak stimulated luteinizing hormone that was measured after a GnRHa stimulation test at Mo 2, 3, and 6. A simple percentage and binomial exact confidence intervals were used in this analysis. Participants who withdrew with luteinizing hormone that remained suppressed were counted as a success. This analysis was performed after the clinical study report was completed and is included to match the FDA package insert.

Outcome measures

Measure	Leuprolide Acetate 11.25 mg - Treatment Naive n=21 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 11.25 mg - Previous Treatment n=21 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Treatment Naive n=21 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Previous Treatment n=21 Participants Subjects who received at least 1 dose of study drug.
Percentage of Participants With Suppression of Peak Stimulated Luteinizing Hormone (< 4 mIU/mL) From Month 2 Through Month 6 (Simple Percentage With Binomial Exact Confidence Intervals)	76.2 Percentage of Participants Interval 52.8 to 91.8	81.0 Percentage of Participants Interval 58.1 to 94.6	90.5 Percentage of Participants Interval 69.6 to 98.8	100.0 Percentage of Participants Interval 83.9 to 100.0

POST_HOC outcome

Timeframe: Baseline to Month 6

Population: The baseline time frame was increased from the secondary outcome to this analysis to include all participants with a bone age radiograph at screening. This analysis was performed post hoc to match the FDA package insert.

The ratio at baseline or Month 6 was calculated as bone age at baseline or Month 6/chronological age at baseline or Month 6. The percentage of participants with a decrease in the ratio was calculated as a simple percentage for each dose group. Observed data were used with no imputation for missing data. The baseline time frame was increased from the secondary outcome in this analysis to include all participants with a bone age radiograph at screening. This analysis was performed after the clinical study report was completed & is included to match the FDA package insert.

Outcome measures

Measure	Leuprolide Acetate 11.25 mg - Treatment Naive n=33 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 11.25 mg - Previous Treatment n=40 Participants Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Treatment Naive Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Previous Treatment Subjects who received at least 1 dose of study drug.
Percentage of Participants With a Decrease From Baseline in the Ratio of Bone Age to Chronological Age at Month 6 Compared to Baseline	87.9 Percentage of Participants	75.0 Percentage of Participants	—	—

Adverse Events

Leuprolide Acetate 11.25 mg - Treatment Naive

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Leuprolide Acetate 11.25 mg - Previous Treatment

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Leuprolide Acetate 30 mg - Treatment Naive

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Leuprolide Acetate 30 mg - Previous Treatment

Serious events: 1 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	Leuprolide Acetate 11.25 mg - Treatment Naive n=21 participants at risk Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 11.25 mg - Previous Treatment n=21 participants at risk Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Treatment Naive n=21 participants at risk Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Previous Treatment n=21 participants at risk Subjects who received at least 1 dose of study drug.
Psychiatric disorders Depression	4.8% 1/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
Gastrointestinal disorders Nausea	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	4.8% 1/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
Gastrointestinal disorders Weight Decreased	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	4.8% 1/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	4.8% 1/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
Gastrointestinal disorders Diarrhea	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	4.8% 1/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.

Other adverse events

Measure	Leuprolide Acetate 11.25 mg - Treatment Naive n=21 participants at risk Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 11.25 mg - Previous Treatment n=21 participants at risk Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Treatment Naive n=21 participants at risk Subjects who received at least 1 dose of study drug.	Leuprolide Acetate 30 mg - Previous Treatment n=21 participants at risk Subjects who received at least 1 dose of study drug.
Injury, poisoning and procedural complications Skin Laceration	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	9.5% 2/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
Investigations Weight Increased	4.8% 1/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	9.5% 2/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	9.5% 2/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	4.8% 1/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
Blood and lymphatic system disorders Lymphadenopathy	4.8% 1/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	4.8% 1/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	9.5% 2/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
Ear and labyrinth disorders Ear Pain	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	4.8% 1/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	9.5% 2/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
Endocrine disorders Goiter	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	9.5% 2/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	4.8% 1/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	19.0% 4/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	4.8% 1/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
General disorders Injection Site Pain	19.0% 4/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	19.0% 4/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	19.0% 4/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	33.3% 7/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
General disorders Pyrexia	9.5% 2/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	9.5% 2/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	9.5% 2/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	28.6% 6/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
Infections and infestations Ear Infection	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	9.5% 2/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
Infections and infestations Gastroenteritis	4.8% 1/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	9.5% 2/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	4.8% 1/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
Infections and infestations Nasopharyngitis	4.8% 1/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	19.0% 4/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	4.8% 1/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	4.8% 1/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
Infections and infestations Otitis Media	9.5% 2/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
Infections and infestations Upper Respiratory Tract Infection	9.5% 2/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	14.3% 3/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	14.3% 3/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	9.5% 2/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
Injury, poisoning and procedural complications Arthropod Bite	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	9.5% 2/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
Musculoskeletal and connective tissue disorders Pain in Extremity	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	9.5% 2/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	4.8% 1/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	9.5% 2/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
Nervous system disorders Dizziness	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	9.5% 2/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
Nervous system disorders Headache	4.8% 1/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	19.0% 4/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	28.6% 6/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	28.6% 6/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
Psychiatric disorders Mood Altered	9.5% 2/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	4.8% 1/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	9.5% 2/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
Respiratory, thoracic and mediastinal disorders Cough	4.8% 1/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	19.0% 4/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	9.5% 2/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	23.8% 5/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
Respiratory, thoracic and mediastinal disorders Nasal congestion	14.3% 3/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	4.8% 1/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	19.0% 4/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	4.8% 1/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal Pain	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	9.5% 2/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	9.5% 2/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory Disorders	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	14.3% 3/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	4.8% 1/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	0.00% 0/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.	14.3% 3/21 • Treatment-emergent adverse events were defined as any event with an onset data after the first dose of study drug and with an onset date no more than 30 days after the last day of study drug treatment which is 84 days after the last injection date. Safety analyses were performed with available data from all subjects who received at least 1 injection of study drug.

Additional Information

Global Medical Services

Abbott

Phone: 800-633-9110

Results disclosure agreements

• Principal investigator is a sponsor employee Abbott 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. Abbott 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 Abbott needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER