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The purpose of this research was to confirm the effectiveness and safety of the study drug, Triptorelin pamoate 15mg 3-month formulation, in a Chinese population of Central Precocious Puberty (CPP) children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triptorelin Pamoate 15mg for injection | Experimental | Triptorelin was injected at day 1 and month 3. If participants were willing to enter the extension phase, two additional Triptorelin injections were given at month 6 and month 9. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Triptorelin pamoate 15mg | Drug | Intramuscular injection (IM) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Luteinising Hormone (LH) Suppression After Gonadotropin-Releasing Hormone (GnRH) Stimulation | 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. | At Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Basal LH and Follicle-Stimulating Hormone (FSH) Serum Levels | 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. | Baseline (Day 1) and at Months 3, 6, 9 and 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chengdu Women's and Children's Central Hospital | Chengdu | 610073 | China | |||
| Jiangxi Provincial Children's Hospital |
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.
Any requests should be submitted to www.vivli.org for assessment by an independent scientific review board.
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Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and EU or after the primary manuscript describing the results has been accepted for publication, whichever is later.
Further details on Ipsen's sharing criteria, eligible studies and process for sharing are available here (https://vivli.org/members/ourmembers/).
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Main Study Phase |
|
| ||||||||||||||||||
| Extension Phase |
|
Intention-To-Treat (ITT) population consisted of all participants who received at least 1 dose of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | All 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Luteinising Hormone (LH) Suppression After Gonadotropin-Releasing Hormone (GnRH) Stimulation | 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. | 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. | Posted | Number | 90% Confidence Interval | percentage of participants | At Month 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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Ipsen Pharma | see email | clinical.trials@ipsen.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 9, 2021 | Apr 6, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 9, 2022 | Apr 6, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011629 | Puberty, Precocious |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D017329 | Triptorelin Pamoate |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Percentage of Participants With LH Suppression After GnRH Stimulation | 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). | At Months 6 and 12 |
| Change From Baseline in Peak LH and FSH Level After GnRH Stimulation | 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. | Baseline (Day 1) and at Months 3, 6 and 12 |
| Percentage of Participants With Prepubertal Levels of Sex Steroids | 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. | At Months 3, 6, 9 and 12 |
| Change From Baseline in Estradiol Levels | 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. | Baseline (Day 1) and at Months 3, 6 ,9 and 12 |
| Change From Baseline in Testosterone Levels | 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. | Baseline (Day 1) and at Months 3, 6 ,9 and 12 |
| Percentage of Participants With Change From Baseline in Pubertal Stage | 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. | Baseline (Day 1) and at Months 6 and 12 |
| Percentage of Participants With Stabilized Pubertal Stage Compared to Baseline | 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. | Baseline (Day 1) and at Months 6 and 12 |
| Change From Baseline in Auxological Parameter: Height | 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. | Baseline (Day 1) and at Months 3, 6, 9 and 12 |
| Change From Baseline in Auxological Parameter: Weight | 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. | Baseline (Day 1) and at Months 3, 6, 9 and 12 |
| Change From Baseline in Auxological Parameter: Growth Velocity | 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. | Baseline (Day 1) and at Months 3, 6, 9 and 12 |
| Change From Baseline in Auxological Parameter: Body Mass Index (BMI) | 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. | Baseline (Day 1) and at Months 3, 6, 9 and 12 |
| Change From Baseline in Bone Age (BA) | 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. | Baseline (Day 1) and at Months 6 and 12 |
| Change From Baseline Difference Between BA and Chronological Age (CA) | 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. | Baseline (Day 1) and at Months 6 and 12 |
| Change From Baseline in Uterine Length | 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. | Baseline (Day 1) and at Months 6 and12 |
| Change From Baseline of Testicular Volume | 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. | Baseline (Day 1) and at Months 6 and 12 |
| Nanchang |
| 330006 |
| China |
| Children's Hospital of Nanjing | Nanjing | 210008 | China |
| Tangshan Maternal & Child Health Hospital | Tangshan | 063000 | China |
| Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology | Wuhan | 430030 | China |
| Wuxi Children's Hospital | Wuxi | 214023 | China |
| Henan Children's Hospital, Zhengzhou Children's Hospital | Zhengzhou | 450018 | China |
|
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
|
|
| Secondary | Change From Baseline in Basal LH and Follicle-Stimulating Hormone (FSH) Serum Levels | 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. | 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. | Posted | Mean | Standard Deviation | IU/L | Baseline (Day 1) and at Months 3, 6, 9 and 12 |
|
|
|
| Secondary | Percentage of Participants With LH Suppression After GnRH Stimulation | 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). | 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. | Posted | Number | 90% Confidence Interval | percentage of participants | At Months 6 and 12 |
|
|
|
| Secondary | Change From Baseline in Peak LH and FSH Level After GnRH Stimulation | 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. | 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. | Posted | Mean | Standard Deviation | IU/L | Baseline (Day 1) and at Months 3, 6 and 12 |
|
|
|
| Secondary | Percentage of Participants With Prepubertal Levels of Sex Steroids | 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. | 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. | Posted | Number | 90% Confidence Interval | percentage of participants | At Months 3, 6, 9 and 12 |
|
|
|
| Secondary | Change From Baseline in Estradiol Levels | 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. | 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. | Posted | Mean | Standard Deviation | pg/mL | Baseline (Day 1) and at Months 3, 6 ,9 and 12 |
|
|
|
| Secondary | Change From Baseline in Testosterone Levels | 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. | 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. | Posted | Mean | Standard Deviation | ng/mL | Baseline (Day 1) and at Months 3, 6 ,9 and 12 |
|
|
|
| Secondary | Percentage of Participants With Change From Baseline in Pubertal Stage | 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. | 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. | Posted | Number | percentage of participants | Baseline (Day 1) and at Months 6 and 12 |
|
|
|
| Secondary | Percentage of Participants With Stabilized Pubertal Stage Compared to Baseline | 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. | 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. | Posted | Number | 90% Confidence Interval | percentage of participants | Baseline (Day 1) and at Months 6 and 12 |
|
|
|
| Secondary | Change From Baseline in Auxological Parameter: Height | 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. | 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. | Posted | Mean | Standard Deviation | centimeter (cm) | Baseline (Day 1) and at Months 3, 6, 9 and 12 |
|
|
|
| Secondary | Change From Baseline in Auxological Parameter: Weight | 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. | 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. | Posted | Mean | Standard Deviation | kilogram (kg) | Baseline (Day 1) and at Months 3, 6, 9 and 12 |
|
|
|
| Secondary | Change From Baseline in Auxological Parameter: Growth Velocity | 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. | 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. | Posted | Mean | Standard Deviation | cm/year | Baseline (Day 1) and at Months 3, 6, 9 and 12 |
|
|
|
| Secondary | Change From Baseline in Auxological Parameter: Body Mass Index (BMI) | 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. | 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. | Posted | Mean | Standard Deviation | kg/meter square | Baseline (Day 1) and at Months 3, 6, 9 and 12 |
|
|
|
| Secondary | Change From Baseline in Bone Age (BA) | 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. | 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. | Posted | Mean | Standard Deviation | years | Baseline (Day 1) and at Months 6 and 12 |
|
|
|
| Secondary | Change From Baseline Difference Between BA and Chronological Age (CA) | 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. | 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. | Posted | Mean | Standard Deviation | years | Baseline (Day 1) and at Months 6 and 12 |
|
|
|
| Secondary | Change From Baseline in Uterine Length | 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. | 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. | Posted | Mean | Standard Deviation | cm | Baseline (Day 1) and at Months 6 and12 |
|
|
|
| Secondary | Change From Baseline of Testicular Volume | 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. | 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. | Posted | Mean | Standard Deviation | mL | Baseline (Day 1) and at Months 6 and 12 |
|
|
|
| 0 |
| 32 |
| 2 |
| 32 |
| 27 |
| 32 |
| Bronchitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
|
| Parotitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA (25.0) | Systematic Assessment |
|
| Abnormal weight gain | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
|
| Overweight | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
|
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
|
| Obesity | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
|
| Hypovitaminosis | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
|
| Impaired fasting glucose | Metabolism and nutrition disorders | MedDRA (25.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
|
| Nasal obstruction | Respiratory, thoracic and mediastinal disorders | MedDRA (25.0) | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
|
| Retained deciduous tooth | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (25.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA (25.0) | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (25.0) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (25.0) | Systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA (25.0) | Systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA (25.0) | Systematic Assessment |
|
| Red blood cells urine | Investigations | MedDRA (25.0) | Systematic Assessment |
|
| Red blood cells urine positive | Investigations | MedDRA (25.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (25.0) | Systematic Assessment |
|
| Dermoid cyst | Congenital, familial and genetic disorders | MedDRA (25.0) | Systematic Assessment |
|
| Myopia | Eye disorders | MedDRA (25.0) | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (25.0) | Systematic Assessment |
|
| Pyogenic granuloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (25.0) | Systematic Assessment |
|
| Tic | Psychiatric disorders | MedDRA (25.0) | Systematic Assessment |
|
| Proteinuria | Renal and urinary disorders | MedDRA (25.0) | Systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (25.0) | Systematic Assessment |
|
Not provided
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
|
| LH, Month 9 |
|
|
| LH, Month 12 |
|
|
| FSH, Month 3 |
|
|
| FSH, Month 6 |
|
|
| FSH, Month 9 |
|
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| FSH, Month 12 |
|
|
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| LH, Month 12 |
|
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| FSH, Month 3 |
|
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| FSH, Month 6 |
|
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| FSH, Month 12 |
|
|
|
| Month 9 |
|
|
| Month 12 |
|
|
|
| Month 9 |
|
|
| Month 12 |
|
|
| Title | Measurements |
|---|---|
|
| Month 12 |
|
|
| Breast development stage for female participants, Month 6, Increased |
|
|
| Breast development stage for female participants, Month 6, Missing |
|
|
| Genital development stage for male participants, Month 6, No change |
|
|
| Genital development stage for male participants, Month 6, Reduced |
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| Genital development stage for male participants, Month 6, Increased |
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| Genital development stage for male participants, Month 6, Missing |
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| Pubic hair development stage for female participants, Month 6, No change |
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| Pubic hair development stage for female participants, Month 6, Reduced |
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| Pubic hair development stage for female participants, Month 6, Increased |
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| Pubic hair development stage for female participants, Month 6, Missing |
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| Pubic hair development stage for male participants, Month 6, No change |
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| Pubic hair development stage for male participants, Month 6, Reduced |
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| Pubic hair development stage for male participants, Month 6, Increased |
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|
| Pubic hair development stage for male participants, Month 6, Missing |
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| Breast development stage for female participants, Month 12, No change |
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| Breast development stage for female participants, Month 12, Reduced |
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| Breast development stage for female participants, Month 12, Increased |
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|
| Breast development stage for female participants, Month 12, Missing |
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| Genital development stage for male participants, Month 12, No change |
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|
| Genital development stage for male participants, Month 12, Reduced |
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|
| Genital development stage for male participants, Month 12, Increased |
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|
| Genital development stage for male participants, Month 12, Missing |
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|
| Pubic hair development stage for female participants, Month 12, No change |
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|
| Pubic hair development stage for female participants, Month 12, Reduced |
|
|
| Pubic hair development stage for female participants, Month 12, Increased |
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|
| Pubic hair development stage for female participants, Month 12, Missing |
|
|
| Pubic hair development stage for male participants, Month 12, No change |
|
|
| Pubic hair development stage for male participants, Month 12, Reduced |
|
|
| Pubic hair development stage for male participants, Month 12, Increased |
|
|
| Pubic hair development stage for male participants, Month 12, Missing |
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| Pubic hair development stage for girls, Month 6 |
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| Pubic hair development stage for boys, Month 6 |
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| Breast development stage for girls, Month 12 |
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| Genital development stage for boys, Month 12 |
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| Pubic hair development stage for girls, Month 12 |
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| Pubic hair development stage for boys, Month 12 |
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| Month 9 |
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| Month 12 |
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| Month 9 |
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| Month 12 |
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| Month 9 |
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| Month 12 |
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| Month 9 |
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| Month 12 |
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| Left, Month 12 |
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| Right, Month 12 |
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