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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-000101-32 | Registry Identifier | EudraCT | |
| NCT04697381 | Registry Identifier | ClinicalTrials.gov |
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This is a multicenter, open label, multi cohort study to evaluate the efficacy and safety of somatropin in a cohort of Japanese participants with PWS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| somatropin - GH naïve pediatric cohort | Experimental | All participants will receive somatropin. |
|
| somatropin - GH treated pediatric cohort | Experimental | All participants will receive somatropin |
|
| somatropin - adult cohort | Experimental | All participants will receive somatropin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| somatropin - GH naïve pediatric cohort | Biological | somatropin 0.245 mg/kg/week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Month 12 in Lean Body Mass Measured by Dual-Energy X-ray Absorptiometry (DEXA): Adult Cohort | Lean body mass, a measurement of body composition, was assessed by DEXA scan, and calculated as lean body mass (%) = lean body mass kilogram (kg) / (lean body mass [kg] + fat mass [kg]) *100. | Baseline, Month 12 |
| Change From Baseline to Month 12 in Lean Body Mass Measured by DEXA: GH Naive Pediatric and GH Treated Pediatric Cohort | Lean body mass, a measurement of body composition, was assessed by DEXA scan, and calculated as lean body mass (%) = lean body mass (kg) / (lean body mass [kg] + fat mass [kg])*100. | Baseline, Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Month 12 in Lean Body Mass Measured by Bioelectrical Impedance Analysis (BIA)-Adult Cohort | Lean body mass, a measurement of body composition, was assessed by DEXA scan, and calculated as lean body mass (%) = lean body mass (kg) / (lean body mass [kg] + fat mass [kg])*100. | Baseline, Month 12 |
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Inclusion Criteria:
Male or female participants with documentation of genetically confirmed diagnosis of PWS.
No plan to initiate a new treatment that may affect the body composition, such as gonadal hormone replacement therapy.
Currently on appropriate diet and exercise programs and willing to continue throughout the study period at the discretion of the investigator.
Participants, and if required by local/site regulations their parent(s)/legal guardian(s) must be willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Evidence of a personally signed and dated ICD (and written assent where applicable based on age and country regulation) indicating that the participant or a legally acceptable representative/parent(s)/legal guardian has been informed of all pertinent aspects of the study. Refer to Appendix 1 for the detailed process of obtaining consent.
For inclusion of GH naïve pediatric cohort, participants must meet criteria 6 to 8:
18 years or younger.
Naïve to GH treatment.
Tanner stage 1 (for testes in males, for breasts in females).
For inclusion of GH treated pediatric cohort, participants must meet criteria 9 and 10:
Continued GH treatment for at least 2 years with stable dose for the last 6 months and being on GH at time of inclusion. The recent dose should be higher than 0.084 mg/kg/week.
Participants who are about to complete GH treatment for his/her short stature (eg, due to meeting the treatment stopping criteria defined as a height SDS more than -2.5 for Japanese adult standards).
For inclusion of adult cohort, participants must meet criteria 11 to 13:
18 years of chronological age or older at Day 1 visit.
Off from GH treatment for at least 1 year.
Serum IGF-I level within +2 SDS, adjusted for age and sex.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanagawa Children's Medical Center | Yokohama | Kanagawa | 232-8555 | Japan | ||
| Osaka Women's and Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40436776 | Derived | Kawai M, Murakami N, Horikawa R, Muroya K, Fujisawa Y, Hoshino Y, Okayama A, Sato T, Ebata N, Ogata T. Improvement in body composition of Japanese participants with Prader-Willi syndrome following somatropin treatment: an open-label, multi cohort Phase 3 study. Endocr J. 2025 Aug 1;72(8):925-935. doi: 10.1507/endocrj.EJ24-0659. Epub 2025 May 28. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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This study had 3 cohorts (GH naive pediatric cohort, GH treated pediatric cohort and adult cohort).
Participants diagnosed with Prader-Willi syndrome (PWS ) received somatropin, a recombinant human growth hormone (r-hGH) in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | GH Naive Pediatric Cohort | Participants 18 years or younger, naive to GH treatment, received somatropin 0.245 milligram per kilogram per week (mg/kg/week) subcutaneously. Treatment period was of 12 months and extension period was of 36 months. Participants were followed up to 28 days. |
| FG001 | GH Treated Pediatric Cohort | Participants 18 years or younger, who continued GH treatment for at least 2 years with stable dose for the last 6 months and were on GH at time of inclusion, received somatropin 0.084 mg/kg/week subcutaneously. The dosage was adjusted according to participants symptoms and insulin-like growth factor 1 (IGF-1) levels with maximum dose up to 1.6 mg/day. Treatment period was of 12 months and extension period was of 36 months. Participants were followed up to 28 days. |
| FG002 | Adult Cohort | Adult participants who were off from GH treatment for at least 1 year, initially received somatropin 0.042 mg/kg/week subcutaneously. Dose was titrated up to 0.084 mg/kg/week from Month 1 visit. The dosage was adjusted according to participants symptoms and serum IGF-1 levels with maximum dose up to 1.6 mg/day. Treatment period was of 12 months and extension period was of 36 months. Participants were followed up to 28 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period |
| |||||||||||||
| Extension Period |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GH Naive Pediatric Cohort | Participants 18 years or younger, naive to GH treatment, received somatropin 0.245 mg/kg/week subcutaneously. Treatment period was of 12 months and extension period was of 36 months. Participants were followed up to 28 days. |
| BG001 | GH Treated Pediatric Cohort |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Change From Baseline to Month 12 in Lean Body Mass Measured by Dual-Energy X-ray Absorptiometry (DEXA): Adult Cohort | Lean body mass, a measurement of body composition, was assessed by DEXA scan, and calculated as lean body mass (%) = lean body mass kilogram (kg) / (lean body mass [kg] + fat mass [kg]) *100. | Efficacy evaluable set included all participants assigned to study intervention and who took at least one dose of study intervention and had at least one efficacy evaluation. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and this time point. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of body mass | Baseline, Month 12 |
|
From Day 1 up to 28 days after end of study treatment (maximum duration up to 38 months)
Same event may appear as both non-SAE and SAE. What is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Analysis population include all participants assigned to study intervention and who took at least one dose of study intervention.
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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 | GH Naive Pediatric Cohort | Participants 18 years or younger, naive to GH treatment, received somatropin 0.245 mg/kg/week subcutaneously. Treatment period was of 12 months and extension period was of 36 months. Participants were followed up to 28 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pain | Ear and labyrinth disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.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 | Dec 13, 2021 | Nov 29, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 16, 2022 | Nov 29, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011218 | Prader-Willi Syndrome |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| somatropin - GH treated cohort | Biological | somatropin 0.084 mg/kg/week |
|
| somatropin - adult cohort | Biological | somatropin 0.084 mg/kg/week |
|
| Change From Baseline to Month 12 in Lean Body Mass Measured by BIA-GH Naive Pediatric and GH Treated Pediatric Cohort |
Lean body mass, a measurement of body composition, was assessed by DEXA scan, and calculated as lean body mass (%) = lean body mass (kg) / (lean body mass [kg] + fat mass [kg])*100. |
| Baseline, Month 12 |
| Change From Baseline to Month 12 in Body Fat (Percentage) Measured by DEXA: Adult Cohort | Body fat was assessed by DEXA scan. and calculated as body fat (%) = body fat (kg) / [lean body mass (kg) + body fat (kg)]*100. | Baseline, Month 12 |
| Change From Baseline to Month 12 in Body Fat (Percentage) Measured by DEXA: GH Naive Pediatric and GH Treated Pediatric Cohort | Body fat was assessed by DEXA scan. and calculated as body fat (%) = body fat (kg) / [lean body mass (kg) + body fat (kg)]*100. | Baseline, Month 12 |
| Change From Baseline to Month 12 in Adipose Tissue Distribution Measured by Abdominal Computed Tomography (CT) | Adipose tissue distribution was measured by abdominal CT. Areas of subcutaneous adipose tissue (SAT) (centimeter square [cm^2]), visceral adipose tissue (VAT) (cm^2) were measured at the level of the umbilicus by abdominal CT. | Baseline, Month 12 |
| Change From Baseline to Month 6 in Lean Body Mass Measured by DEXA: Adult Cohort Only | Lean body mass, a measurement of body composition, was assessed by DEXA scan, and calculated as lean body mass (%) = lean body mass (kg) / (lean body mass [kg] + fat mass [kg])*100. | Baseline, Month 6 |
| Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events | An adverse event was any untoward medical occurrence in administered medicinal product, event need not necessarily have a causal relationship with product treatment or usage. A serious adverse event was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Treatment emergent AEs were events emerged during treatment period and were absent before treatment or that worsened relative to pretreatment state. TEAEs consist of SAEs and non-SAEs | From day 1 up to 28 days after end of study treatment (maximum duration up to 38 months) |
| Number of Participants With Laboratory Test Abnormalities | Criteria for abnormal laboratory values for chemistry parameters: alanine aminotransferase, alkaline phosphatase greater than (>) 3.0*upper limit of normal (ULN), albumin > 1.2*ULN, urea nitrogen millimoles per liter (mmol/L) > 1.3*ULN, HDL cholesterol mmol/L less than (<) 0.8* lower limit of normal (LLN), LDL cholesterol mmol/L >1.2*ULN, triglycerides mmol/L > 1.3*ULN, thyrotropin milliunits per liter (mU/L) <0.8*LLN and >1.2*ULN, glucose (mmol/L) >1.5*ULN, hemoglobin A1C liter of cells per liter of blood (L/L) >1.3*ULN. | From Day 1 up to 28 days after end of study treatment (maximum duration up to 38 months) |
| Bone Maturation | Bone maturation is the process whereby the tissue undergoes changes from the embryonic rudiment of bone to the adult form. Bone maturation was calculated as bone age divided by chronological age. Participants with bone maturation value greater than 1 is presented in this outcome measure. | 12 months |
| Izumi |
| Osaka |
| 594-1101 |
| Japan |
| Dokkyo Medical University Saitama Medical Center | Koshigaya | Saitama | 343-8555 | Japan |
| Hamamatsu University Hospital | Hamamatsu | Shizuoka | 431-3192 | Japan |
| National Center for Child Health and Development | Setagaya-ku | Tokyo | 157-8535 | Japan |
| NOT COMPLETED |
|
|
Participants 18 years or younger, who continued GH treatment for at least 2 years with stable dose for the last 6 months and were on GH at time of inclusion, received somatropin 0.084 mg/kg/week subcutaneously. The dosage was adjusted according to participants symptoms and IGF-1 levels with maximum dose up to 1.6 mg/day. Treatment period was of 12 months and extension period was of 36 months. Participants were followed up to 28 days. |
| BG002 | Adult Cohort | Adult participants who were off from GH treatment for at least 1 year, initially received somatropin 0.042 mg/kg/week subcutaneously. Dose was titrated up to 0.084 mg/kg/week from Month 1 visit. The dosage was adjusted according to participants symptoms and serum IGF-1 levels with maximum dose up to 1.6 mg/day. Treatment period was of 12 months and extension period was of 36 months. Participants were followed up to 28 days. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Change From Baseline to Month 12 in Lean Body Mass Measured by DEXA: GH Naive Pediatric and GH Treated Pediatric Cohort | Lean body mass, a measurement of body composition, was assessed by DEXA scan, and calculated as lean body mass (%) = lean body mass (kg) / (lean body mass [kg] + fat mass [kg])*100. | Efficacy evaluable set included all participants assigned to study intervention and who took at least one dose of study intervention and had at least one efficacy evaluation. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and this time point. | Posted | Mean | Standard Deviation | Percentage of body mass | Baseline, Month 12 |
|
|
|
| Secondary | Change From Baseline to Month 12 in Lean Body Mass Measured by Bioelectrical Impedance Analysis (BIA)-Adult Cohort | Lean body mass, a measurement of body composition, was assessed by DEXA scan, and calculated as lean body mass (%) = lean body mass (kg) / (lean body mass [kg] + fat mass [kg])*100. | Efficacy evaluable set included all participants assigned to study intervention and who took at least one dose of study intervention and had at least one efficacy evaluation. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and this time point. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of body mass | Baseline, Month 12 |
|
|
|
| Secondary | Change From Baseline to Month 12 in Lean Body Mass Measured by BIA-GH Naive Pediatric and GH Treated Pediatric Cohort | Lean body mass, a measurement of body composition, was assessed by DEXA scan, and calculated as lean body mass (%) = lean body mass (kg) / (lean body mass [kg] + fat mass [kg])*100. | Efficacy evaluable set included all participants assigned to study intervention and who took at least one dose of study intervention and had at least one efficacy evaluation. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and this time point. | Posted | Mean | Standard Deviation | Percentage of body mass | Baseline, Month 12 |
|
|
|
| Secondary | Change From Baseline to Month 12 in Body Fat (Percentage) Measured by DEXA: Adult Cohort | Body fat was assessed by DEXA scan. and calculated as body fat (%) = body fat (kg) / [lean body mass (kg) + body fat (kg)]*100. | Efficacy evaluable set included all participants assigned to study intervention and who took at least one dose of study intervention and had at least one efficacy evaluation. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and this time point. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of body fat | Baseline, Month 12 |
|
|
|
| Secondary | Change From Baseline to Month 12 in Body Fat (Percentage) Measured by DEXA: GH Naive Pediatric and GH Treated Pediatric Cohort | Body fat was assessed by DEXA scan. and calculated as body fat (%) = body fat (kg) / [lean body mass (kg) + body fat (kg)]*100. | Efficacy evaluable set included all participants assigned to study intervention and who took at least one dose of study intervention and had at least one efficacy evaluation. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and this time point. | Posted | Mean | Standard Deviation | Percentage of body fat | Baseline, Month 12 |
|
|
|
| Secondary | Change From Baseline to Month 12 in Adipose Tissue Distribution Measured by Abdominal Computed Tomography (CT) | Adipose tissue distribution was measured by abdominal CT. Areas of subcutaneous adipose tissue (SAT) (centimeter square [cm^2]), visceral adipose tissue (VAT) (cm^2) were measured at the level of the umbilicus by abdominal CT. | Efficacy evaluable set included all participants assigned to study intervention and who took at least one dose of study intervention and had at least one efficacy evaluation. Here "Number of Participants Analyzed" signifies participants evaluable for this outcome measure and this time point. | Posted | Mean | Standard Deviation | Centimeter square (cm^2) | Baseline, Month 12 |
|
|
|
| Secondary | Change From Baseline to Month 6 in Lean Body Mass Measured by DEXA: Adult Cohort Only | Lean body mass, a measurement of body composition, was assessed by DEXA scan, and calculated as lean body mass (%) = lean body mass (kg) / (lean body mass [kg] + fat mass [kg])*100. | Efficacy evaluable set included all participants assigned to study intervention and who took at least one dose of study intervention and had at least one efficacy evaluation. | Posted | Least Squares Mean | 95% Confidence Interval | Percentage of body mass | Baseline, Month 6 |
|
|
|
| Secondary | Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events | An adverse event was any untoward medical occurrence in administered medicinal product, event need not necessarily have a causal relationship with product treatment or usage. A serious adverse event was any untoward medical occurrence in a participant administered a medicinal or nutritional product (including pediatric formulas) at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); resulted in congenital anomaly/birth defect. Treatment emergent AEs were events emerged during treatment period and were absent before treatment or that worsened relative to pretreatment state. TEAEs consist of SAEs and non-SAEs | Full analysis set (FAS) included all participants assigned to study intervention and who took at least one dose of study intervention. | Posted | Count of Participants | Participants | From day 1 up to 28 days after end of study treatment (maximum duration up to 38 months) |
|
|
|
| Secondary | Number of Participants With Laboratory Test Abnormalities | Criteria for abnormal laboratory values for chemistry parameters: alanine aminotransferase, alkaline phosphatase greater than (>) 3.0*upper limit of normal (ULN), albumin > 1.2*ULN, urea nitrogen millimoles per liter (mmol/L) > 1.3*ULN, HDL cholesterol mmol/L less than (<) 0.8* lower limit of normal (LLN), LDL cholesterol mmol/L >1.2*ULN, triglycerides mmol/L > 1.3*ULN, thyrotropin milliunits per liter (mU/L) <0.8*LLN and >1.2*ULN, glucose (mmol/L) >1.5*ULN, hemoglobin A1C liter of cells per liter of blood (L/L) >1.3*ULN. | FAS included all participants assigned to study intervention and who took at least one dose of study intervention. | Posted | Count of Participants | Participants | From Day 1 up to 28 days after end of study treatment (maximum duration up to 38 months) |
|
|
|
| Secondary | Bone Maturation | Bone maturation is the process whereby the tissue undergoes changes from the embryonic rudiment of bone to the adult form. Bone maturation was calculated as bone age divided by chronological age. Participants with bone maturation value greater than 1 is presented in this outcome measure. | FAS included all participants assigned to study intervention and who took at least one dose of study intervention. | Posted | Number | Participants | 12 months |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | GH Treated Pediatric Cohort | Participants 18 years or younger, who continued GH treatment for at least 2 years with stable dose for the last 6 months and were on GH at time of inclusion, received somatropin 0.084 mg/kg/week subcutaneously. The dosage was adjusted according to participants symptoms and IGF-1 levels with maximum dose up to 1.6 mg/day. Treatment period was of 12 months and extension period was of 36 months. Participants were followed up to 28 days. | 0 | 7 | 1 | 7 | 7 | 7 |
| EG002 | Adult Cohort | Adult participants who were off from GH treatment for at least 1 year, initially received somatropin 0.042 mg/kg/week subcutaneously. Dose was titrated up to 0.084 mg/kg/week from Month 1 visit. The dosage was adjusted according to participants symptoms and serum IGF-1 levels with maximum dose up to 1.6 mg/day. Treatment period was of 12 months and extension period was of 36 months. Participants were followed up to 28 days. | 0 | 20 | 3 | 20 | 19 | 20 |
| Brain contusion | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
|
| Skull fractured base | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Sinus node dysfunction | Cardiac disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Seizure | Nervous system disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Affect lability | Psychiatric disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Anal prolapse | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Angular cheilitis | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Extravasation | General disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Immunisation reaction | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
|
| Eczema impetiginous | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
|
| Genital candidiasis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
|
| Chillblains | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
|
| Limb injury | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
|
| Lip injury | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
|
| Subcutaneous haematoma | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
|
| Body height increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
|
| Glycosylated haemoglobin increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
|
| Insulin-like growth factor increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
|
| Liver function test increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
|
| SARS-CoV-2 test positive | Investigations | MedDRA v25.1 | Non-systematic Assessment |
|
| Abnormal weight gain | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Glucose tolerance impaired | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Pseudohypoglycaemia | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Conversion disorder | Psychiatric disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Dissociative disorder | Psychiatric disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Testicular pain | Reproductive system and breast disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Snoring | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Hand dermatitis | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Miliaria | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Deafness unilateral | Ear and labyrinth disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Ear pruritus | Ear and labyrinth disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Blepharitis | Eye disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Eczema eyelids | Eye disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Glaucoma | Eye disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Anal polyp | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Hypoaesthesia teeth | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
|
| Genital abscess | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
|
| Herpangina | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Dermatitis diaper | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Cough variant asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Genital tract inflammation | Reproductive system and breast disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Dysphoria | Psychiatric disorders | MedDRA v26.1 | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA v26.1 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v26.1 | Non-systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA v26.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D000096803 | Imprinting Disorders |
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
|
| Title | Measurements |
|---|---|
|