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The purpose of this study is to evaluate the clinical efficacy and safety in Japanese adult subjects with Intra-abdominal/Pelvic infections receiving Metronidazole IV 1,500-2,000 mg/day in combination with ceftriaxone sodium.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metronidazole | Experimental | Metronidazole will be administered at a dose of 500 mg TID (or QID for refractory or severe infection) in combination with ceftriaxone sodium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metronidazole | Drug | Metronidazole will be administered at a dose of 500 mg TID (or QID for refractory or severe infection) for 3 to 14 days, in principle. Treatment duration can be prolonged up to 21 days based on subject's condition. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response: Response Rate (Data Review Committee Assessment) | Clinical response was evaluated by the data review committee as effective (cured or improved), ineffective (not meeting "effective" criteria), or indeterminate at the end of treatment (EOT) and the test of cure (TOC: 7 days after EOT) based on clinical symptoms, ultrasound images and necessity of other treatment. TOC was the primary analysis of this outcome measure. Cured = clinical symptoms and abnormal findings at the start of the study were disappeared and considered other antibiotics were not required during the study and after the assessment time point. Improved = clinical symptoms and abnormal findings at the start of the study were improved and considered other antibiotics were not required during the study and after the assessment time point. Response rate was calculated from the following formula; "number of participants evaluated as effective" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100. | Baseline to EOT (up to 14 days), TOC |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response: Response Rate (Investigator Assessment) | Clinical response was evaluated by the investigator as effective (cured or improved), ineffective (not meeting "effective" criteria), or indeterminate at the end of treatment (EOT) and the test of cure (TOC: 7 days after EOT) based on clinical symptoms, ultrasound images and necessity of other treatment. TOC was the primary analysis of this outcome measure. Cured = clinical symptoms and abnormal findings at the start of the study were disappeared and considered other antibiotics were not required during the study and after the assessment time point. Improved = clinical symptoms and abnormal findings at the start of the study were improved and considered other antibiotics were not required during the study and after the assessment time point. Response rate was calculated from the following formula; "number of participants evaluated as effective" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daiyukai First Hospital | Ichinomiya | Aichi-ken | Japan | |||
| Hirosaki National Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25442806 | Derived | Mikamo H, Matsumizu M, Nakazuru Y, Nagashima M. Efficacy and safety of metronidazole injection for the treatment of infectious peritonitis, abdominal abscess and pelvic inflammatory diseases in Japan. J Infect Chemother. 2015 Feb;21(2):96-104. doi: 10.1016/j.jiac.2014.10.005. Epub 2014 Nov 28. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Metronidazole/Ceftriaxone | Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Metronidazole/Ceftriaxone | Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Clinical Response: Response Rate (Data Review Committee Assessment) | Clinical response was evaluated by the data review committee as effective (cured or improved), ineffective (not meeting "effective" criteria), or indeterminate at the end of treatment (EOT) and the test of cure (TOC: 7 days after EOT) based on clinical symptoms, ultrasound images and necessity of other treatment. TOC was the primary analysis of this outcome measure. Cured = clinical symptoms and abnormal findings at the start of the study were disappeared and considered other antibiotics were not required during the study and after the assessment time point. Improved = clinical symptoms and abnormal findings at the start of the study were improved and considered other antibiotics were not required during the study and after the assessment time point. Response rate was calculated from the following formula; "number of participants evaluated as effective" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100. | Clinical per protocol set consisted of all participants who received at least one dose of study medication, had no significant protocol deviation, and underwent planned assessments. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as "indeterminate". | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to EOT (up to 14 days), TOC |
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | Metronidazole/Ceftriaxone | Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infectious peritonitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | 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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| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D000292 | Pelvic Inflammatory Disease |
| ID | Term |
|---|---|
| D007239 | Infections |
| D034161 | Pelvic Infection |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
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| ID | Term |
|---|---|
| D008795 | Metronidazole |
| D002443 | Ceftriaxone |
| ID | Term |
|---|---|
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
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| Ceftriaxone sodium | Drug | Ceftriaxone sodium will be administered at a daily dose of 2 g (strength) when metronidazole is administered TID or at a daily dose of 4 g (strength) when metronidazole is administered QID. |
|
|
| Baseline to EOT (up to 14 days), TOC |
| Percentage of Participants Who Was Assessed as Appropriate to Continue Treatment (Investigator Assessment) | The appropriateness of treatment continuation was evaluated on Day 4 by the investigator as continuation, discontinuation or indeterminate based on the clinical response. The percentage of participants was calculated from the following formula; "number of participants assessed as continuation" over "total number of participants that excluding ones assessed as indeterminate" multiplied by 100. | Baseline to Day 4 |
| Bacteriological Response: Eradication Rate (Data Review Committee Assessment) | Bacteriological response was evaluated as eradication (eradication, presumed eradication or colonization), persistence, or indeterminate by the data review committee, at Day 4, at the end of treatment (EOT), and the test of cure (TOC: 7 days after EOT). Eradication Rate was calculated from the following formula, "number of participants with bacteria eradication, presumed eradication or colonization" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100. | Baseline to Day 4, EOT (up to 14 days), TOC |
| Bacteriological Response: Eradication Rate (Investigator Assessment) | Bacteriological response was evaluated as eradication (eradication, presumed eradication or colonization), persistence, or indeterminate by the investigator at the end of treatment (EOT), and the test of cure (TOC: 7 days after EOT). Eradication Rate was calculated from the following formula, "number of participants with bacteria eradication, presumed eradication or colonization" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100. | Baseline to Day 4, EOT (up to 14 days), TOC |
| Number of Participants Analyzed for Population Pharmacokinetics (PK) of Metronidazole | Population pharmacokinetic analysis of Metronidazole is conducted by combining current study data with other Metronidazole studies. | Four samples were taken at any infusion after the first dosing: during infusion, immediately after end of infusion, between 15 and 60 minutes after end of infusion, and between 2 hours and immediately before the start of the next infusion. |
| Hirosaki |
| Aomori |
| Japan |
| National Hospital Organization Chiba Medical Center | Chiba | Chiba | Japan |
| National Hospital Organization Kokura Medical Center | Kitakyushu | Fukuoka | Japan |
| National Hospital Organization Fukuyama Medical Center | Fukuyama | Hiroshima | Japan |
| Hitachi General Hospital | Hitachi | Ibaraki | Japan |
| Kawasaki Saiwai Hospital | Kawasaki | Kanagawa | Japan |
| Kumamoto Saishunso National Hospital | Koushi | Kumamoto | Japan |
| National Hospital Organization Kumamoto Medical Center | Kumamoto | Kumamoto | Japan |
| National Hospital Organization Sendai Medical Center | Sendai | Miyagi | Japan |
| Iida Municipal Hospital | Iida | Nagano | Japan |
| Nagano Prefectural Suzaka Hospital | Suzaka-shi | Nagano | Japan |
| National Hospital Organization Nagasaki Medical Center | Ohmura | Nagasaki | Japan |
| National Hospital Organization Osaka Minami Medical Center | Kawachi-Nagano | Osaka | Japan |
| Koshigaya Municipal Hospital | Koshigaya | Saitama | Japan |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| Secondary | Clinical Response: Response Rate (Investigator Assessment) | Clinical response was evaluated by the investigator as effective (cured or improved), ineffective (not meeting "effective" criteria), or indeterminate at the end of treatment (EOT) and the test of cure (TOC: 7 days after EOT) based on clinical symptoms, ultrasound images and necessity of other treatment. TOC was the primary analysis of this outcome measure. Cured = clinical symptoms and abnormal findings at the start of the study were disappeared and considered other antibiotics were not required during the study and after the assessment time point. Improved = clinical symptoms and abnormal findings at the start of the study were improved and considered other antibiotics were not required during the study and after the assessment time point. Response rate was calculated from the following formula; "number of participants evaluated as effective" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100. | Clinical per protocol set consisted of all participants who received at least one dose of study medication, had no significant protocol deviation, and underwent planned assessments. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as "indeterminate". | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to EOT (up to 14 days), TOC |
|
|
|
| Secondary | Percentage of Participants Who Was Assessed as Appropriate to Continue Treatment (Investigator Assessment) | The appropriateness of treatment continuation was evaluated on Day 4 by the investigator as continuation, discontinuation or indeterminate based on the clinical response. The percentage of participants was calculated from the following formula; "number of participants assessed as continuation" over "total number of participants that excluding ones assessed as indeterminate" multiplied by 100. | Clinical per protocol set consisted of all participants who received at least one dose of study medication, had no significant protocol deviation, and underwent planned assessments. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as "indeterminate". | Posted | Number | percentage of participants | Baseline to Day 4 |
|
|
|
| Secondary | Bacteriological Response: Eradication Rate (Data Review Committee Assessment) | Bacteriological response was evaluated as eradication (eradication, presumed eradication or colonization), persistence, or indeterminate by the data review committee, at Day 4, at the end of treatment (EOT), and the test of cure (TOC: 7 days after EOT). Eradication Rate was calculated from the following formula, "number of participants with bacteria eradication, presumed eradication or colonization" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100. | Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified on Day 1 prior to the initial dose. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as "indeterminate". | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to Day 4, EOT (up to 14 days), TOC |
|
|
|
| Secondary | Bacteriological Response: Eradication Rate (Investigator Assessment) | Bacteriological response was evaluated as eradication (eradication, presumed eradication or colonization), persistence, or indeterminate by the investigator at the end of treatment (EOT), and the test of cure (TOC: 7 days after EOT). Eradication Rate was calculated from the following formula, "number of participants with bacteria eradication, presumed eradication or colonization" over "total number of participants that excluding ones evaluated as indeterminate" multiplied by 100. | Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified on Day 1 prior to the initial dose. No imputation was used for missing data. n = number of participants assessed that excluding ones evaluated as "indeterminate". | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to Day 4, EOT (up to 14 days), TOC |
|
|
|
| Secondary | Number of Participants Analyzed for Population Pharmacokinetics (PK) of Metronidazole | Population pharmacokinetic analysis of Metronidazole is conducted by combining current study data with other Metronidazole studies. | No population pharmacokinetic analysis results are available just for the current study. | Posted | Four samples were taken at any infusion after the first dosing: during infusion, immediately after end of infusion, between 15 and 60 minutes after end of infusion, and between 2 hours and immediately before the start of the next infusion. |
|
|
| 4 |
| 38 |
| 30 |
| 38 |
| Pelvic inflammatory disease | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Retroperitoneal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Stress cardiomyopathy | Cardiac disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Ileus | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Ileus paralytic | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Proctalgia | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Injection site extravasation | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Instillation site erythema | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Injection site infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Gastrointestinal stoma necrosis | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Postoperative wound complication | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 15.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Blood sodium decreased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Platelet count increased | Investigations | MedDRA 15.1 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Hypoproteinaemia | Metabolism and nutrition disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Incontinence | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications 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.
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|