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A study to describe and evaluate patient characteristics and clinical outcomes in Subjects with diagnosed Non Small Lung Cell Cancer in Sweden, Norway and Denmark.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: National patient cohorts in Scandinavia | Scandinavian countries: Denmark, Norway and Sweden Cohort 1 will include all patients with a diagnosis of NSCLC between 2005 and 2013 | ||
| Cohort 2: Electronic Medical Records based cohort (Sweden) | Patient as data is available (~2010) to 2013 |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival based on Response Evaluation Criteria in Solid Tumors (RECIST) | Overall survival is defined as the time from start of treatment to the end of follow-up; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease | Approximately 2 years |
| Progression free survival based on Response Evaluation Criteria in Solid Tumors (RECIST) | Progression free survival is defined as the time from date of treatment start to either the first disease progression date or last known tumor assessment date or death; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease | Approximately 2 years |
| Time to progression based on Response Evaluation Criteria in Solid Tumors (RECIST) | Time to progression is defined as time from start of therapy until tumor progression; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease | Approximately 2 years |
| Disease control rate; defined as total number of patients whose Best Overall Response(BOR)= Complete Response(CR), Partial Response(PR) or Stable Disease(SD), divided by total number of patients | Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease; BOR: Best Overall Response, CR: Complete Response, PR: Partial Response, SD: Stable Disease | Approximately 2 years |
| Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST) | Partial response is defined as a record of at least a 30% decrease in the sum of diameters of target lesions, from the baseline sum; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index (BMI) of NSCLC patients at diagnosis | At baseline visit | |
| Smoking habits of NSCLC patients at diagnosis | At baseline visit | |
| Age of NSCLC patients at diagnosis |
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Inclusion Criteria:
Patients with a histologically confirmed diagnosis of NSCLC (squamous, adenocarcinoma, not otherwise specified NSCLC [NSCLC NOS]) identified in the Cancer registers
Exclusion Criteria:
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Patients with a diagnosis of NSCLC
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| Approximately 2 years |
| Complete response based on Response Evaluation Criteria in Solid Tumors (RECIST) | Complete response is defined as a record of disappearance of all target lesions; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease | Approximately 2 years |
| Percent of patients with an adverse event (AE) | Patients with advanced stage (stage IIIB and above) disease; AEs are defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product | Approximately 2 years |
| Percent of patients with an adverse event (AE) | Patients with earlier stage (stages I to IIA) disease; AEs are defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product | Approximately 2 years |
| At baseline visit |
| NSCLC clinical subtype of NSCLC patients at diagnosis | At baseline visit |
| Tumor node metastasis classification of NSCLC patients at diagnosis | At baseline visit |
| Charlson Comorbidity index of NSCLC patients at diagnosis | At baseline visit |
| Drug utilization after NSCLC diagnosis by line of therapy | Approximately 2 years |
| Proportion of patients who receive surgery by stage at treatment | Approximately 2 years |
| Proportion of patients who receive radiation by stage at treatment | Approximately 2 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |