Trial Outcomes & Findings for Efficacy and Safety Study of Triptorelin 3-Month Formulation in Chinese Children With Central Precocious Puberty. (NCT NCT04736602)
NCT ID: NCT04736602
Last Updated: 2024-08-01
Results Overview
The LH suppression was defined as stimulated peak LH ≤3 International Units/Liter (IU/L). The GnRH stimulation test was performed by using an intravenous (IV) injection of gonadorelin (synthetic GnRH) to stimulate gonadotrophin release and blood samples were collected after the gonadorelin injection for central assessment of serum LH levels.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
32 participants
Primary outcome timeframe
At Month 3
Results posted on
2024-08-01
Participant Flow
This prospective, Phase 3, open-label, single arm, 2-phase (main study phase and an extension phase) study was conducted in children with central precocious puberty (CPP) at 6 investigational sites in China.
This study consisted of screening period (up to 28 days), main study phase (6 months) and an optional extension phase (6 months). A total of 32 participants were enrolled in this study.
Participant milestones
| Measure |
All Participants
Participants received triptorelin pamoate 15 milligrams (mg) intramuscular (IM) injection on Day 1 visit and Month 3 visit (Day 91) during the main study phase. Participants had an option to continue with the triptorelin pamoate in extension phase of the study. As per Investigator decision, eligible participants continued to receive IM injections of triptorelin pamoate on Month 6 (Day 182) and Month 9 (Day 271) during the extension phase.
|
|---|---|
|
Main Study Phase
STARTED
|
32
|
|
Main Study Phase
COMPLETED
|
30
|
|
Main Study Phase
NOT COMPLETED
|
2
|
|
Extension Phase
STARTED
|
30
|
|
Extension Phase
COMPLETED
|
29
|
|
Extension Phase
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
All Participants
Participants received triptorelin pamoate 15 milligrams (mg) intramuscular (IM) injection on Day 1 visit and Month 3 visit (Day 91) during the main study phase. Participants had an option to continue with the triptorelin pamoate in extension phase of the study. As per Investigator decision, eligible participants continued to receive IM injections of triptorelin pamoate on Month 6 (Day 182) and Month 9 (Day 271) during the extension phase.
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|---|---|
|
Main Study Phase
Withdrawal by Parent/Guardian
|
2
|
|
Extension Phase
Withdrawal by Parent/Guardian
|
1
|
Baseline Characteristics
Efficacy and Safety Study of Triptorelin 3-Month Formulation in Chinese Children With Central Precocious Puberty.
Baseline characteristics by cohort
| Measure |
All Participants
n=32 Participants
Participants received triptorelin pamoate 15 mg IM injection on Day 1 visit and Month 3 visit (Day 91) during the main study phase. Participants had an option to continue with the triptorelin pamoate in extension phase of the study. As per Investigator decision, eligible participants continued to receive IM injections of triptorelin pamoate on Month 6 (Day 182) and Month 9 (Day 271) during the extension phase.
|
|---|---|
|
Age, Categorical
<=18 years
|
32 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
7.6 years
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
32 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Month 3Population: The modified ITT (mITT) population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint.
The LH suppression was defined as stimulated peak LH ≤3 International Units/Liter (IU/L). The GnRH stimulation test was performed by using an intravenous (IV) injection of gonadorelin (synthetic GnRH) to stimulate gonadotrophin release and blood samples were collected after the gonadorelin injection for central assessment of serum LH levels.
Outcome measures
| Measure |
All Participants
n=31 Participants
Participants received triptorelin pamoate 15 mg IM injection on Day 1 visit and Month 3 visit (Day 91) during the main study phase. Participants had an option to continue with the triptorelin pamoate in extension phase of the study. As per Investigator decision, eligible participants continued to receive IM injections of triptorelin pamoate on Month 6 (Day 182) and Month 9 (Day 271) during the extension phase.
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|---|---|
|
Percentage of Participants With Luteinising Hormone (LH) Suppression After Gonadotropin-Releasing Hormone (GnRH) Stimulation
|
100 percentage of participants
Interval 90.8 to 100.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Months 3, 6, 9 and 12Population: The mITT population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint. Only data from the participants analyzed were reported.
Basal LH and FSH serum concentrations were analyzed centrally. Change from baseline was defined as the value for LH and FSH levels at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first dose administered.
Outcome measures
| Measure |
All Participants
n=31 Participants
Participants received triptorelin pamoate 15 mg IM injection on Day 1 visit and Month 3 visit (Day 91) during the main study phase. Participants had an option to continue with the triptorelin pamoate in extension phase of the study. As per Investigator decision, eligible participants continued to receive IM injections of triptorelin pamoate on Month 6 (Day 182) and Month 9 (Day 271) during the extension phase.
|
|---|---|
|
Change From Baseline in Basal LH and Follicle-Stimulating Hormone (FSH) Serum Levels
LH, Month 3
|
-0.6906 IU/L
Standard Deviation 1.6417
|
|
Change From Baseline in Basal LH and Follicle-Stimulating Hormone (FSH) Serum Levels
LH, Month 6
|
-0.7411 IU/L
Standard Deviation 1.6606
|
|
Change From Baseline in Basal LH and Follicle-Stimulating Hormone (FSH) Serum Levels
LH, Month 9
|
-0.7415 IU/L
Standard Deviation 1.6817
|
|
Change From Baseline in Basal LH and Follicle-Stimulating Hormone (FSH) Serum Levels
LH, Month 12
|
-0.9310 IU/L
Standard Deviation 1.6367
|
|
Change From Baseline in Basal LH and Follicle-Stimulating Hormone (FSH) Serum Levels
FSH, Month 3
|
-2.3531 IU/L
Standard Deviation 1.8079
|
|
Change From Baseline in Basal LH and Follicle-Stimulating Hormone (FSH) Serum Levels
FSH, Month 6
|
-2.2307 IU/L
Standard Deviation 1.7445
|
|
Change From Baseline in Basal LH and Follicle-Stimulating Hormone (FSH) Serum Levels
FSH, Month 9
|
-2.0740 IU/L
Standard Deviation 1.7979
|
|
Change From Baseline in Basal LH and Follicle-Stimulating Hormone (FSH) Serum Levels
FSH, Month 12
|
-1.9413 IU/L
Standard Deviation 1.6996
|
SECONDARY outcome
Timeframe: At Months 6 and 12Population: The mITT population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint. Only data from the participants analyzed were reported.
A synthetic GnRH (gonadorelin) was used for gonadotrophin stimulation. Blood samples were collected prior to gonadorelin injection (timepoint T0) and at 30 minutes (T30), 60 minutes (T60) and 90 minutes (T90) (±5 minutes at each timepoint) after a single IV injection of gonadorelin. A suppressed LH response to GnRH stimulation test was defined as peak LH ≤3 IU/L among the 4 timepoints T0, T30, T60 and T90).
Outcome measures
| Measure |
All Participants
n=29 Participants
Participants received triptorelin pamoate 15 mg IM injection on Day 1 visit and Month 3 visit (Day 91) during the main study phase. Participants had an option to continue with the triptorelin pamoate in extension phase of the study. As per Investigator decision, eligible participants continued to receive IM injections of triptorelin pamoate on Month 6 (Day 182) and Month 9 (Day 271) during the extension phase.
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|---|---|
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Percentage of Participants With LH Suppression After GnRH Stimulation
Month 6
|
93.5 percentage of participants
Interval 81.1 to 98.8
|
|
Percentage of Participants With LH Suppression After GnRH Stimulation
Month 12
|
93.5 percentage of participants
Interval 81.1 to 98.8
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Months 3, 6 and 12Population: The mITT population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint. Only data from the participants analyzed were reported.
A synthetic GnRH was used for gonadotrophin stimulation. Blood samples were collected prior to gonadorelin injection (timepoint T0) and at 30 minutes (T30), 60 minutes (T60) and 90 minutes (T90) (±5 minutes at each timepoint) after a single IV injection of gonadorelin. The FSH response to GnRH stimulation was the peak FSH level among the 4 timepoints (T0, T30, T60 and T90). The LH response to GnRH stimulation test was defined as peak LH ≤3 IU/L among the 4 timepoints T0, T30, T60 and T90). Baseline was defined as the last non-missing measurement taken prior to the first dose administered.
Outcome measures
| Measure |
All Participants
n=31 Participants
Participants received triptorelin pamoate 15 mg IM injection on Day 1 visit and Month 3 visit (Day 91) during the main study phase. Participants had an option to continue with the triptorelin pamoate in extension phase of the study. As per Investigator decision, eligible participants continued to receive IM injections of triptorelin pamoate on Month 6 (Day 182) and Month 9 (Day 271) during the extension phase.
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|---|---|
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Change From Baseline in Peak LH and FSH Level After GnRH Stimulation
LH, Month 3
|
-23.0969 IU/L
Standard Deviation 17.9856
|
|
Change From Baseline in Peak LH and FSH Level After GnRH Stimulation
LH, Month 6
|
-24.3596 IU/L
Standard Deviation 17.9180
|
|
Change From Baseline in Peak LH and FSH Level After GnRH Stimulation
LH, Month 12
|
-23.7221 IU/L
Standard Deviation 18.3669
|
|
Change From Baseline in Peak LH and FSH Level After GnRH Stimulation
FSH, Month 3
|
-11.2757 IU/L
Standard Deviation 4.5026
|
|
Change From Baseline in Peak LH and FSH Level After GnRH Stimulation
FSH, Month 6
|
-11.2536 IU/L
Standard Deviation 4.5267
|
|
Change From Baseline in Peak LH and FSH Level After GnRH Stimulation
FSH, Month 12
|
-10.4701 IU/L
Standard Deviation 4.8424
|
SECONDARY outcome
Timeframe: At Months 3, 6, 9 and 12Population: The mITT population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint. Only data from the participants analyzed were reported.
Prepubertal sex steroids assessment included estradiol in female participants and testosterone in male participants. Prepubertal sex steroids levels were defined as: estradiol ≤20 picogram (pg)/milliliter (mL) in female participants and testosterone ≤0.3 nanogram (ng)/mL in male participants.
Outcome measures
| Measure |
All Participants
n=31 Participants
Participants received triptorelin pamoate 15 mg IM injection on Day 1 visit and Month 3 visit (Day 91) during the main study phase. Participants had an option to continue with the triptorelin pamoate in extension phase of the study. As per Investigator decision, eligible participants continued to receive IM injections of triptorelin pamoate on Month 6 (Day 182) and Month 9 (Day 271) during the extension phase.
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|---|---|
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Percentage of Participants With Prepubertal Levels of Sex Steroids
Month 3
|
100 percentage of participants
Interval 90.8 to 100.0
|
|
Percentage of Participants With Prepubertal Levels of Sex Steroids
Month 6
|
96.8 percentage of participants
Interval 85.6 to 99.8
|
|
Percentage of Participants With Prepubertal Levels of Sex Steroids
Month 9
|
90.3 percentage of participants
Interval 76.8 to 97.3
|
|
Percentage of Participants With Prepubertal Levels of Sex Steroids
Month 12
|
93.5 percentage of participants
Interval 81.1 to 98.8
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Months 3, 6 ,9 and 12Population: The mITT population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint. Only data for female participants were analyzed.
Estradiol serum concentration was analyzed centrally. Change from baseline was defined as the value for estradiol levels at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first dose administered.
Outcome measures
| Measure |
All Participants
n=28 Participants
Participants received triptorelin pamoate 15 mg IM injection on Day 1 visit and Month 3 visit (Day 91) during the main study phase. Participants had an option to continue with the triptorelin pamoate in extension phase of the study. As per Investigator decision, eligible participants continued to receive IM injections of triptorelin pamoate on Month 6 (Day 182) and Month 9 (Day 271) during the extension phase.
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|---|---|
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Change From Baseline in Estradiol Levels
Month 3
|
-8.0047 pg/mL
Standard Deviation 15.6905
|
|
Change From Baseline in Estradiol Levels
Month 6
|
-8.3011 pg/mL
Standard Deviation 15.9093
|
|
Change From Baseline in Estradiol Levels
Month 9
|
-7.7458 pg/mL
Standard Deviation 15.8683
|
|
Change From Baseline in Estradiol Levels
Month 12
|
-8.6204 pg/mL
Standard Deviation 16.1359
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Months 3, 6 ,9 and 12Population: The mITT population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint. Only data for male participants were analyzed.
Testosterone serum concentration was analyzed centrally. Change from baseline was defined as the value for testosterone levels at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first dose administered.
Outcome measures
| Measure |
All Participants
n=3 Participants
Participants received triptorelin pamoate 15 mg IM injection on Day 1 visit and Month 3 visit (Day 91) during the main study phase. Participants had an option to continue with the triptorelin pamoate in extension phase of the study. As per Investigator decision, eligible participants continued to receive IM injections of triptorelin pamoate on Month 6 (Day 182) and Month 9 (Day 271) during the extension phase.
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|---|---|
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Change From Baseline in Testosterone Levels
Month 3
|
-1.3650 ng/mL
Standard Deviation 1.1734
|
|
Change From Baseline in Testosterone Levels
Month 6
|
-1.3650 ng/mL
Standard Deviation 1.1734
|
|
Change From Baseline in Testosterone Levels
Month 9
|
-1.3650 ng/mL
Standard Deviation 1.1734
|
|
Change From Baseline in Testosterone Levels
Month 12
|
-1.3650 ng/mL
Standard Deviation 1.1734
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Months 6 and 12Population: The mITT population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint. Only data from the participants analyzed were reported.
Pubertal stage parameters were analyzed using Tanner method. Pubertal stage parameters included genital stage in male participants, breast stage in female participants and pubic hair stage in both sexes.
Outcome measures
| Measure |
All Participants
n=31 Participants
Participants received triptorelin pamoate 15 mg IM injection on Day 1 visit and Month 3 visit (Day 91) during the main study phase. Participants had an option to continue with the triptorelin pamoate in extension phase of the study. As per Investigator decision, eligible participants continued to receive IM injections of triptorelin pamoate on Month 6 (Day 182) and Month 9 (Day 271) during the extension phase.
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|---|---|
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Percentage of Participants With Change From Baseline in Pubertal Stage
Breast development stage for female participants, Month 6, No change
|
35.7 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Breast development stage for female participants, Month 6, Reduced
|
57.1 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Breast development stage for female participants, Month 6, Increased
|
3.6 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Breast development stage for female participants, Month 6, Missing
|
3.6 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Genital development stage for male participants, Month 6, No change
|
33.3 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Genital development stage for male participants, Month 6, Reduced
|
66.7 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Genital development stage for male participants, Month 6, Increased
|
0 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Genital development stage for male participants, Month 6, Missing
|
0 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Pubic hair development stage for female participants, Month 6, No change
|
96.4 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Pubic hair development stage for female participants, Month 6, Reduced
|
0 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Pubic hair development stage for female participants, Month 6, Increased
|
0 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Pubic hair development stage for female participants, Month 6, Missing
|
3.6 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Pubic hair development stage for male participants, Month 6, No change
|
66.7 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Pubic hair development stage for male participants, Month 6, Reduced
|
33.3 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Pubic hair development stage for male participants, Month 6, Increased
|
0 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Pubic hair development stage for male participants, Month 6, Missing
|
0 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Breast development stage for female participants, Month 12, No change
|
39.3 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Breast development stage for female participants, Month 12, Reduced
|
50.0 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Breast development stage for female participants, Month 12, Increased
|
3.6 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Breast development stage for female participants, Month 12, Missing
|
7.1 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Genital development stage for male participants, Month 12, No change
|
0 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Genital development stage for male participants, Month 12, Reduced
|
100 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Genital development stage for male participants, Month 12, Increased
|
0 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Genital development stage for male participants, Month 12, Missing
|
0 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Pubic hair development stage for female participants, Month 12, No change
|
82.1 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Pubic hair development stage for female participants, Month 12, Reduced
|
0 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Pubic hair development stage for female participants, Month 12, Increased
|
10.7 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Pubic hair development stage for female participants, Month 12, Missing
|
7.1 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Pubic hair development stage for male participants, Month 12, No change
|
66.7 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Pubic hair development stage for male participants, Month 12, Reduced
|
33.3 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Pubic hair development stage for male participants, Month 12, Increased
|
0 percentage of participants
|
|
Percentage of Participants With Change From Baseline in Pubertal Stage
Pubic hair development stage for male participants, Month 12, Missing
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Months 6 and 12Population: The mITT population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint. Only data from the participants analyzed were reported.
Pubertal stage parameters were analyzed using Tanner method. Pubertal stage parameters included genital stage in male participants, breast stage in female participants and pubic hair stage in both sexes.
Outcome measures
| Measure |
All Participants
n=31 Participants
Participants received triptorelin pamoate 15 mg IM injection on Day 1 visit and Month 3 visit (Day 91) during the main study phase. Participants had an option to continue with the triptorelin pamoate in extension phase of the study. As per Investigator decision, eligible participants continued to receive IM injections of triptorelin pamoate on Month 6 (Day 182) and Month 9 (Day 271) during the extension phase.
|
|---|---|
|
Percentage of Participants With Stabilized Pubertal Stage Compared to Baseline
Breast development stage for girls, Month 6
|
92.9 percentage of participants
Interval 79.2 to 98.7
|
|
Percentage of Participants With Stabilized Pubertal Stage Compared to Baseline
Genital development stage for boys, Month 6
|
100 percentage of participants
Interval 36.8 to 100.0
|
|
Percentage of Participants With Stabilized Pubertal Stage Compared to Baseline
Pubic hair development stage for girls, Month 6
|
96.4 percentage of participants
Interval 84.1 to 99.8
|
|
Percentage of Participants With Stabilized Pubertal Stage Compared to Baseline
Pubic hair development stage for boys, Month 6
|
100 percentage of participants
Interval 36.8 to 100.0
|
|
Percentage of Participants With Stabilized Pubertal Stage Compared to Baseline
Breast development stage for girls, Month 12
|
89.3 percentage of participants
Interval 74.6 to 97.0
|
|
Percentage of Participants With Stabilized Pubertal Stage Compared to Baseline
Genital development stage for boys, Month 12
|
100 percentage of participants
Interval 36.8 to 100.0
|
|
Percentage of Participants With Stabilized Pubertal Stage Compared to Baseline
Pubic hair development stage for girls, Month 12
|
82.1 percentage of participants
Interval 66.1 to 92.7
|
|
Percentage of Participants With Stabilized Pubertal Stage Compared to Baseline
Pubic hair development stage for boys, Month 12
|
100 percentage of participants
Interval 36.8 to 100.0
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Months 3, 6, 9 and 12Population: The mITT population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint. Only data from the participants analyzed were reported.
Auxological parameter including height was analyzed. Change from baseline was defined as the value for each auxological parameter at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first dose administered.
Outcome measures
| Measure |
All Participants
n=31 Participants
Participants received triptorelin pamoate 15 mg IM injection on Day 1 visit and Month 3 visit (Day 91) during the main study phase. Participants had an option to continue with the triptorelin pamoate in extension phase of the study. As per Investigator decision, eligible participants continued to receive IM injections of triptorelin pamoate on Month 6 (Day 182) and Month 9 (Day 271) during the extension phase.
|
|---|---|
|
Change From Baseline in Auxological Parameter: Height
Month 3
|
2.24 centimeter (cm)
Standard Deviation 0.62
|
|
Change From Baseline in Auxological Parameter: Height
Month 6
|
3.55 centimeter (cm)
Standard Deviation 0.69
|
|
Change From Baseline in Auxological Parameter: Height
Month 9
|
4.63 centimeter (cm)
Standard Deviation 0.81
|
|
Change From Baseline in Auxological Parameter: Height
Month 12
|
6.54 centimeter (cm)
Standard Deviation 0.88
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Months 3, 6, 9 and 12Population: The mITT population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint. Only data from the participants analyzed were reported.
Auxological parameter including weight was analyzed. Change from baseline was defined as the value for each auxological parameter at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first dose administered.
Outcome measures
| Measure |
All Participants
n=31 Participants
Participants received triptorelin pamoate 15 mg IM injection on Day 1 visit and Month 3 visit (Day 91) during the main study phase. Participants had an option to continue with the triptorelin pamoate in extension phase of the study. As per Investigator decision, eligible participants continued to receive IM injections of triptorelin pamoate on Month 6 (Day 182) and Month 9 (Day 271) during the extension phase.
|
|---|---|
|
Change From Baseline in Auxological Parameter: Weight
Month 3
|
1.284 kilogram (kg)
Standard Deviation 1.319
|
|
Change From Baseline in Auxological Parameter: Weight
Month 6
|
2.533 kilogram (kg)
Standard Deviation 1.647
|
|
Change From Baseline in Auxological Parameter: Weight
Month 9
|
3.290 kilogram (kg)
Standard Deviation 1.899
|
|
Change From Baseline in Auxological Parameter: Weight
Month 12
|
4.818 kilogram (kg)
Standard Deviation 2.385
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Months 3, 6, 9 and 12Population: The mITT population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint. Only data from the participants analyzed were reported.
Auxological parameter including growth velocity was analyzed. Change from baseline was defined as the value for each auxological parameter at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first dose administered.
Outcome measures
| Measure |
All Participants
n=31 Participants
Participants received triptorelin pamoate 15 mg IM injection on Day 1 visit and Month 3 visit (Day 91) during the main study phase. Participants had an option to continue with the triptorelin pamoate in extension phase of the study. As per Investigator decision, eligible participants continued to receive IM injections of triptorelin pamoate on Month 6 (Day 182) and Month 9 (Day 271) during the extension phase.
|
|---|---|
|
Change From Baseline in Auxological Parameter: Growth Velocity
Month 3
|
-0.895 cm/year
Standard Deviation 3.637
|
|
Change From Baseline in Auxological Parameter: Growth Velocity
Month 6
|
-3.769 cm/year
Standard Deviation 2.806
|
|
Change From Baseline in Auxological Parameter: Growth Velocity
Month 9
|
-4.804 cm/year
Standard Deviation 2.927
|
|
Change From Baseline in Auxological Parameter: Growth Velocity
Month 12
|
-2.052 cm/year
Standard Deviation 3.089
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Months 3, 6, 9 and 12Population: The mITT population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint. Only data from the participants analyzed were reported.
Auxological parameter including BMI was analyzed. Change from baseline was defined as the value for each auxological parameter at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first dose administered.
Outcome measures
| Measure |
All Participants
n=31 Participants
Participants received triptorelin pamoate 15 mg IM injection on Day 1 visit and Month 3 visit (Day 91) during the main study phase. Participants had an option to continue with the triptorelin pamoate in extension phase of the study. As per Investigator decision, eligible participants continued to receive IM injections of triptorelin pamoate on Month 6 (Day 182) and Month 9 (Day 271) during the extension phase.
|
|---|---|
|
Change From Baseline in Auxological Parameter: Body Mass Index (BMI)
Month 3
|
0.142 kg/meter square
Standard Deviation 0.702
|
|
Change From Baseline in Auxological Parameter: Body Mass Index (BMI)
Month 6
|
0.470 kg/meter square
Standard Deviation 0.791
|
|
Change From Baseline in Auxological Parameter: Body Mass Index (BMI)
Month 9
|
0.585 kg/meter square
Standard Deviation 0.849
|
|
Change From Baseline in Auxological Parameter: Body Mass Index (BMI)
Month 12
|
0.895 kg/meter square
Standard Deviation 1.081
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Months 6 and 12Population: The mITT population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint. Only data from the participants analyzed were reported.
BA was determined using X-rays of the hand and wrist. Change from baseline was defined as the value for BA at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first dose administered.
Outcome measures
| Measure |
All Participants
n=30 Participants
Participants received triptorelin pamoate 15 mg IM injection on Day 1 visit and Month 3 visit (Day 91) during the main study phase. Participants had an option to continue with the triptorelin pamoate in extension phase of the study. As per Investigator decision, eligible participants continued to receive IM injections of triptorelin pamoate on Month 6 (Day 182) and Month 9 (Day 271) during the extension phase.
|
|---|---|
|
Change From Baseline in Bone Age (BA)
Month 6
|
0.233 years
Standard Deviation 0.307
|
|
Change From Baseline in Bone Age (BA)
Month 12
|
0.586 years
Standard Deviation 0.544
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Months 6 and 12Population: The mITT population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint. Only data from the participants analyzed were reported.
BA was determined using X-rays of the hand and wrist. Change from baseline was defined as the difference between BA and CA value at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first dose administered.
Outcome measures
| Measure |
All Participants
n=30 Participants
Participants received triptorelin pamoate 15 mg IM injection on Day 1 visit and Month 3 visit (Day 91) during the main study phase. Participants had an option to continue with the triptorelin pamoate in extension phase of the study. As per Investigator decision, eligible participants continued to receive IM injections of triptorelin pamoate on Month 6 (Day 182) and Month 9 (Day 271) during the extension phase.
|
|---|---|
|
Change From Baseline Difference Between BA and Chronological Age (CA)
Month 6
|
-0.44 years
Standard Deviation 0.53
|
|
Change From Baseline Difference Between BA and Chronological Age (CA)
Month 12
|
-0.48 years
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Months 6 and12Population: The mITT population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint. Only data from the female participants analyzed were reported.
Uterine length was determined by type B ultrasound. Change from baseline was defined as the value of uterine length at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first dose administered.
Outcome measures
| Measure |
All Participants
n=28 Participants
Participants received triptorelin pamoate 15 mg IM injection on Day 1 visit and Month 3 visit (Day 91) during the main study phase. Participants had an option to continue with the triptorelin pamoate in extension phase of the study. As per Investigator decision, eligible participants continued to receive IM injections of triptorelin pamoate on Month 6 (Day 182) and Month 9 (Day 271) during the extension phase.
|
|---|---|
|
Change From Baseline in Uterine Length
Month 6
|
-0.4012 cm
Standard Deviation 0.4391
|
|
Change From Baseline in Uterine Length
Month 12
|
-0.3771 cm
Standard Deviation 0.6534
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Months 6 and 12Population: The mITT population consisted of all treated participants with at least 1 baseline and Month 3 post-baseline assessment of the primary efficacy endpoint. Only data from the male participants analyzed were reported. The Number Analyzed for left and right are not consistent for each month because one participant did not have the examination on the left testicular throughout the study.
Testicular volume was determined by type B ultrasound. Change from baseline was defined as the value of testicular volume at indicated timepoints minus the value at baseline. Baseline was defined as the last non-missing measurement taken prior to the first dose administered.
Outcome measures
| Measure |
All Participants
n=3 Participants
Participants received triptorelin pamoate 15 mg IM injection on Day 1 visit and Month 3 visit (Day 91) during the main study phase. Participants had an option to continue with the triptorelin pamoate in extension phase of the study. As per Investigator decision, eligible participants continued to receive IM injections of triptorelin pamoate on Month 6 (Day 182) and Month 9 (Day 271) during the extension phase.
|
|---|---|
|
Change From Baseline of Testicular Volume
Right, Month 12
|
-6.7975 mL
Standard Deviation 6.3958
|
|
Change From Baseline of Testicular Volume
Left, Month 6
|
-2.4022 mL
Standard Deviation 1.7109
|
|
Change From Baseline of Testicular Volume
Right, Month 6
|
-4.7334 mL
Standard Deviation 4.4222
|
|
Change From Baseline of Testicular Volume
Left, Month 12
|
-2.8840 mL
Standard Deviation NA
NA indicates that standard deviation could not be calculated as only 1 participant was analyzed.
|
Adverse Events
All Participants
Serious events: 2 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Participants
n=32 participants at risk
Participants received triptorelin pamoate 15 mg IM injection on Day 1 visit and Month 3 visit (Day 91) during the main study phase. Participants had an option to continue with the triptorelin pamoate in extension phase of the study. As per Investigator decision, eligible participants continued to receive IM injections of triptorelin pamoate on Month 6 (Day 182) and Month 9 (Day 271) during the extension phase.
|
|---|---|
|
Infections and infestations
Pneumonia
|
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
Other adverse events
| Measure |
All Participants
n=32 participants at risk
Participants received triptorelin pamoate 15 mg IM injection on Day 1 visit and Month 3 visit (Day 91) during the main study phase. Participants had an option to continue with the triptorelin pamoate in extension phase of the study. As per Investigator decision, eligible participants continued to receive IM injections of triptorelin pamoate on Month 6 (Day 182) and Month 9 (Day 271) during the extension phase.
|
|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
31.2%
10/32 • Number of events 15 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Bronchitis
|
9.4%
3/32 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Tonsillitis
|
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Gastroenteritis
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Gingivitis
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Hordeolum
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Parotitis
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Pneumonia
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Respiratory tract infection
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Infections and infestations
Rhinitis
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Abnormal weight gain
|
21.9%
7/32 • Number of events 7 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Overweight
|
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Obesity
|
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypovitaminosis
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
Impaired fasting glucose
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.4%
3/32 • Number of events 3 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.4%
3/32 • Number of events 4 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
3.1%
1/32 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Dental caries
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Gastritis
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Retained deciduous tooth
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
3.1%
1/32 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
General disorders
Pyrexia
|
6.2%
2/32 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
General disorders
Chest discomfort
|
3.1%
1/32 • Number of events 2 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
General disorders
Condition aggravated
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Investigations
Blood creatinine increased
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Investigations
Red blood cells urine
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Investigations
Red blood cells urine positive
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Congenital, familial and genetic disorders
Dermoid cyst
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Eye disorders
Myopia
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Psychiatric disorders
Tic
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Renal and urinary disorders
Proteinuria
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
3.1%
1/32 • Number of events 1 • Treatment-emergent adverse events were reported from the first dose of study treatment (Day 1) up to end of extension phase, a maximum of approximately 368 days.
Safety population consisted of all participants who received at least 1 dose of study medication and had at least 1 post-baseline safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER