| Primary | Percentage of Participants With V600 BRAF Mutation Status | Presence or absence of mutations in the V600 BRAF oncogene was determined in all eligible participants. Data collection and management of BRAF mutation testing was carried out using the Biomarker pointĀ® online platform. The platform was used as an electronic case report form (e-CRF) for collecting information in electronic format via a website. Percentage of participants with BRAF mutation status (mutated BRAF, wild type, not available) were reported. | All enrolled participants were included in the analysis. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Day 1 | | | | ID | Title | Description |
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| OG000 | Metastatic Melanoma | Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study. |
| | | Title | Denominators | Categories |
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| Mutated BRAF | | | | Wild type | | | | Not available | | |
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| Secondary | Percentage of Participants Categorized by Melanoma Stage | Melanoma stages were categorized (according to American Joint Committee on Cancer [AJCC]) as IIIc (advanced stage of melanoma), M1a (metastases to skin, subcutaneous, or distant lymph nodes, normal lactate dehydrogenase (LDH) level, M1b (lung metastases, normal LDH) and M1c (metastases to all other visceral sites and normal LDH or distant metastases to any site combined with an elevated serum LDH level). Of these Stage IIIc was used as the referral category for comparisons. | All participants enrolled in the study were included in the analysis. | Posted | | Number | | percentage of participants | | Day 1 | | | | ID | Title | Description |
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| OG000 | Metastatic Melanoma | Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study. |
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| Secondary | Percentage of Participants With Family History of Melanoma | | All participants enrolled in the study were included in the analysis. | Posted | | Number | | percentage of participants | | Day 1 | | | | ID | Title | Description |
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| OG000 | Metastatic Melanoma | Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study. |
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| Secondary | Percentage of Participants With Sun Exposure | Data were obtained to classify the population with sun exposure as those with low, intermittent or chronic exposure. For the sub-analysis of low, intermittent and chronic exposure, percentages were calculated based on the population with any sun exposure. | All participants enrolled in the study were included in the analysis. | Posted | | Number | | percentage of participants | | Day 1 | | | | ID | Title | Description |
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| OG000 | Metastatic Melanoma | Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study. |
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| Secondary | Percentage of Participants Categorized by Primary Tumor Location | Primary tumor location included limbs (upper and lower extremities), trunk, head/neck, mucosa, uveal, acral, other (other than these specified locations), unknown (exact location unknown), and not available. | All participants enrolled in the study were included in the analysis. | Posted | | Number | | percentage of participants | | Day 1 | | | | ID | Title | Description |
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| OG000 | Metastatic Melanoma | Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study. |
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| Secondary | Percentage of Participants Categorized By LDH Level | Normal LDH levels range from 140 units per liter (U/L) to 280 U/L. | All participants enrolled in the study were included in the analysis. | Posted | | Number | | percentage of participants | | Day 1 | | | | ID | Title | Description |
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| OG000 | Metastatic Melanoma | Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study. |
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| Secondary | Median Time Since Diagnosis of Melanoma | Median time from the diagnosis of primary melanoma to advanced disease was determined in years. | All participants enrolled in the study were included in the analysis except for one participant with missing data. | Posted | | Median | Full Range | years | | Day 1 | | | | ID | Title | Description |
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| OG000 | Metastatic Melanoma | Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study. |
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| Secondary | Percentage of Participants Categorized by Tumor Sample Source (Primary Tumor or Metastatic Sites) | | All participants enrolled in the study were included in the analysis. | Posted | | Number | | percentage of participants | | Day 1 | | | | ID | Title | Description |
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| OG000 | Metastatic Melanoma | Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study. |
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| Secondary | Percentage of Participants Categorized by Tumor Sample Type (Paraffin-embedded Tissue Blocks, Paraffin Block Slides, Cytology Slides, or Other) | | All participants enrolled in the study were included in the analysis. | Posted | | Number | | percentage of participants | | Day 1 | | | | ID | Title | Description |
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| OG000 | Metastatic Melanoma | Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study. |
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| Secondary | Percentage of Participants Categorized by Method of Fixation (Buffered Formalin or Others) | | All participants enrolled in the study were included in the analysis. | Posted | | Number | | percentage of participants | | Day 1 | | | | ID | Title | Description |
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| OG000 | Metastatic Melanoma | Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study. |
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| Secondary | Percentage of Participants Categorized by Breslow Thickness | Breslow thickness is defined as the total vertical height of the melanoma, from the very top (called the granular layer) to the area of deepest penetration in the skin. An instrument called an ocular micrometer is used to measure the thickness of the excised (removed) tumor. In general, the higher the Breslow thickness, the worse the prognosis. The classifications were lesser than or equal to (ā¤) 1.0 millimeters (mm), 1.01 - 2.0 mm, 2.01 - 4.0 mm, greater than (>) 4.0 mm and Unknown. | All participants enrolled in the study were included in the analysis. | Posted | | Number | | percentage of participants | | Day 1 | | | | ID | Title | Description |
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| OG000 | Metastatic Melanoma | Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study. |
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| Secondary | Percentage of Participants With Ulceration | | All participants enrolled in the study were included in the analysis | Posted | | Number | | percentage of participants | | Day 1 | | | | ID | Title | Description |
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| OG000 | Metastatic Melanoma | Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study. |
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| Secondary | Percentage of Participants With Regression | Regression in melanoma is the replacement of tumor tissue with fibrosis, degenerated melanoma cells, lymphocytic proliferation, and telangiectasia formation. | All participants enrolled in the study were included in the analysis. | Posted | | Number | | percentage of participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Metastatic Melanoma | Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study. |
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| Secondary | Percentage of Participants With Vascular Invasion | Vascular invasion is defined as the appearance of cancer cells in the lymphatic and blood streams. | All participants enrolled in the study were included in the analysis. | Posted | | Number | | percentage of participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Metastatic Melanoma | Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study. |
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| Secondary | Percentage of Participants Categorized by Method of DNA Extraction (CobasĀ® BRAF V600 Mutation Test or Others) | | All participants enrolled in the study were included in the analysis. | Posted | | Number | | percentage of participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Metastatic Melanoma | Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study. |
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| Secondary | Percentage of Participants Categorized by Method of BRAF Mutation Testing (CobasĀ® 4800 BRAF V600 Mutation Test or Others) | | All participants enrolled in the study were included in the analysis. | Posted | | Number | | percentage of participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Metastatic Melanoma | Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study. |
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| Secondary | Percentage Participants Categorized by the Percentage of Tumor Cells Referred to the Technique | The samples were classified based on the percentage of tumor cells referred to the technique as follows: <60 percent (%), 60-80%, >80% and Unknown. | All participants enrolled in the study were included in the analysis. | Posted | | Number | | percentage of participants | | Day 1 | | | | ID | Title | Description |
|---|
| OG000 | Metastatic Melanoma | Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study. |
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| Secondary | Percentage of Participants With Adequate Quality/Quantity of Tumor Sample | | All participants enrolled in the study were included in the analysis. | Posted | | Number | | percentage of participants | | Day 1 | | | | ID | Title | Description |
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| OG000 | Metastatic Melanoma | Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study. |
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