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Characteristics of patients with Neuregulin-1 (NRG1) gene fusion-positive solid tumors treated with afatinib, and characteristics of those treated with another systemic therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All afatinib patients |
| ||
| All non-afatinib (other systemic therapies) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Afatinib | Drug | Afatinib |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR): Based on Charted/Physician-reported Disease Response | ORR was defined as the percentage of patients with a complete response (CR) or partial response (PR) out of all patients (CR+PR/all patients) at initial response assessment and best response (response based on the scan where the patient showed the best response to treatment (not progression)). Charted/physician-reported (physician-provided information as recorded in patient's chart) ORR is reported. | From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days. |
| Objective Response Rate (ORR): Based on Lesion Measurements and RECIST v1.1 Criteria | ORR based on lesion measurements and RECIST v1.1 criteria is reported. ORR was defined as the percentage of patients with a complete response (CR) or partial response (PR) out of all patients (CR+PR/all patients) at initial response assessment and best response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): CR: Disappearance of all target lesions or disappearance of all non-target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days. |
| Duration of Objective Response (DOR) | DOR was defined as the time from initial response (for any patient with a complete or partial response initially) until the earliest of either disease progression or death. Duration of response is reported for those patients who had a complete or partial response according to charted/physician-reported disease response. Patients who discontinued therapy due to a reason other than progression were censored on the date of discontinuation. Patients still on therapy at the time of data cut-off were censored on their last visit date. | From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days. |
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Inclusion Criteria:
Exclusion Criteria:
- Treatment with any Tyrosine kinase inhibitor (TKI)/ErbB-directed therapy other than afatinib
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Providers will select patients meeting the study eligibility criteria as described below. Providers will be asked to select eligible patients chronologically, starting with the first patient who first initiated any line of afatinib or chemotherapy, on or after 01/01/2017 through 03/31/2020.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardinal Health | Dublin | Ohio | 43017 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents, except for the following exclusions:
For more details refer to: https://www.mystudywindow.com/msw/datasharing
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Only subjects that met all inclusion and none of the exclusion criteria were included.
This was a non-interventional, retrospective, United States (US), multi-site, cohort study based on existing data from medical records of patients with Neuregulin-1 (NRG1) gene fusion-positive solid tumors treated with afatinib or other systemic therapy.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Afatinib Patients | Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2020 |
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| other systemic therapy | Drug | other systemic therapy |
|
| Duration of Clinical Benefit (DOCB) | DOCB was defined as the time from initial response (for any patient with a complete, partial, or stable disease response initially) until the earliest of either disease progression or death. DOCB reported for those patients who had a complete, partial or response according to charted/physician-reported disease response. Patients who discontinued therapy due to a reason other than progression were censored on the date of discontinuation. Patients still on therapy at the time of data cut-off were censored on their last visit date. | From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days. |
| Progression Free Survival (PFS) | PFS was defined as time from initiation of a line of therapy until disease progression or death; patients on therapy at the time of data cut-off were censored on the last date of treatment. Patients who discontinued a line of therapy for a reason other than disease progression but who subsequently die prior to the receipt of any other therapy were considered an event on the date of death. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): Progressive disease (PD): at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 millimeter (mm). | From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days. |
| Time on Treatment (TOT) | TOT was defined as time from initiation of a line of therapy until discontinuation for any reason. Patients on therapy at the time of data cut-off were censored on the last date of treatment. | From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days. |
| Time to Progression (TTP) | TTP was defined as time from initiation of a line of therapy until discontinuation due to disease progression. Patients on therapy or those who discontinued due to a reason other than disease progression were censored on the last date of treatment. | From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days. |
| Overall Survival (OS) | OS was defined as time from initiation of any therapy in the metastatic setting until death. Patients alive at the time of data cut-off were censored on the last date the patient was seen by the provider/clinic. | From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days. |
| Number of Patients Who Experienced Any ADRs During Index Treatment Line | Number of patients who experienced any averse drug reactions (ADRs) during index treatment line is reported. An ADR was defined as a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event (AE) is at least a reasonable possibility. | From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days. |
| FG001 | All Non-afatinib (Other Systemic Therapies) | Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up). |
| First Line Therapy Patients |
|
| COMPLETED | Patients receiving index therapy at data collection (i.e.11-November-2020 to 20-January-2021) |
|
| NOT COMPLETED |
|
|
All patients who initiated index therapy (i.e., afatinib in any line; other systemic therapy among those without any history of afatinib) between 01 January 2017 and 31 March 2020.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Afatinib Patients | Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up). |
| BG001 | All Non-afatinib (Other Systemic Therapies) | Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up). |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at initiation of index therapy. | Median | Inter-Quartile Range | Years |
| ||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Geographic Region | Number of patients in each category of Geographic Region is reported. The reported categories of geographic region are: Northeast; Midwest; South; West. | Count of Participants | Participants |
| |||||||||||||||
| Line of therapy in which index therapy was received | Number of patients in each category of line of therapy in which index therapy was received is reported. The reported categories of line of therapy are: First line (1L); Second line (2L);
| Count of Participants | Participants |
| |||||||||||||||
| Eastern Cooperative Oncology Group Performance Status (ECOG-PS) | Eastern Cooperative Oncology Group Performance Status (ECOG-PS) describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability (walking, working, etc.). It is measured on a 6 point scale, from 0 to 5, with 0 meaning the patient is fully active without restrictions and 5 death. Number of patients in each reported category of ECOG-PS at the time of initiation of index therapy is reported. The reported categories of ECOG-PS are: 0 or 1; 2+ (i.e.. includes 2,3,4). | Count of Participants | Participants |
| |||||||||||||||
| Smoking status at initiation of index therapy | Number of patients in each category of smoking status at initiation of index therapy. The reported categories of smoking status are: Never smoked; Current smoker; Past history of smoking. | Count of Participants | Participants |
| |||||||||||||||
| Tumor stage at initiation of index therapy | Number of patients in each category of tumor stage at initiation of index therapy is reported. The reported categories of tumor stage are: Stage I; Stage II; Stage III; Stage IV. | Count of Participants | Participants |
| |||||||||||||||
| Comorbidities | Number of patients in each category of comorbidities. The reported categories of comorbidities are: Hypertension; Cardiovascular disease; Diabetes with chronic complications; Chronic pulmonary disease; None of the above. | Count of Participants | Participants |
| |||||||||||||||
| NRG1 testing characteristics: NRG1 testing location | Number of patients in each category of Neuregulin 1 (NRG1) testing locations is reported. The reported categories of NRG1 testing locations are: Caris Life Sciences; Foundation One; Other; Specialty gene testing lab; Tempus; Unknown. | Count of Participants | 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 | Objective Response Rate (ORR): Based on Charted/Physician-reported Disease Response | ORR was defined as the percentage of patients with a complete response (CR) or partial response (PR) out of all patients (CR+PR/all patients) at initial response assessment and best response (response based on the scan where the patient showed the best response to treatment (not progression)). Charted/physician-reported (physician-provided information as recorded in patient's chart) ORR is reported. | All patients who initiated index therapy (i.e., afatinib in any line; other systemic therapy among those without any history of afatinib) between 01 January 2017 and 31 March 2020. | Posted | Number | percentage of patients | From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days. |
|
|
| |||||||||||||||||||||||||||||||||||
| Primary | Objective Response Rate (ORR): Based on Lesion Measurements and RECIST v1.1 Criteria | ORR based on lesion measurements and RECIST v1.1 criteria is reported. ORR was defined as the percentage of patients with a complete response (CR) or partial response (PR) out of all patients (CR+PR/all patients) at initial response assessment and best response. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): CR: Disappearance of all target lesions or disappearance of all non-target lesions. PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. | All patients who initiated index therapy (i.e., afatinib in any line; other systemic therapy among those without any history of afatinib) between 01 January 2017 and 31 March 2020. | Posted | Number | percentage of patients | From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days. |
| |||||||||||||||||||||||||||||||||||||
| Primary | Duration of Objective Response (DOR) | DOR was defined as the time from initial response (for any patient with a complete or partial response initially) until the earliest of either disease progression or death. Duration of response is reported for those patients who had a complete or partial response according to charted/physician-reported disease response. Patients who discontinued therapy due to a reason other than progression were censored on the date of discontinuation. Patients still on therapy at the time of data cut-off were censored on their last visit date. | All patients who initiated index therapy (i.e., afatinib in any line; other systemic therapy among those without any history of afatinib) between 01 January 2017 and 31 March 2020 and had a complete or partial response according to charted/physician-reported disease response. | Posted | Median | 95% Confidence Interval | months | From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days. |
| ||||||||||||||||||||||||||||||||||||
| Primary | Duration of Clinical Benefit (DOCB) | DOCB was defined as the time from initial response (for any patient with a complete, partial, or stable disease response initially) until the earliest of either disease progression or death. DOCB reported for those patients who had a complete, partial or response according to charted/physician-reported disease response. Patients who discontinued therapy due to a reason other than progression were censored on the date of discontinuation. Patients still on therapy at the time of data cut-off were censored on their last visit date. | All patients who initiated index therapy (i.e., afatinib in any line; other systemic therapy among those without any history of afatinib) between 01 January 2017 and 31 March 2020 and had a complete, partial, or stable disease response according to charted/physician-reported disease response. | Posted | Median | 95% Confidence Interval | months | From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days. |
| ||||||||||||||||||||||||||||||||||||
| Primary | Progression Free Survival (PFS) | PFS was defined as time from initiation of a line of therapy until disease progression or death; patients on therapy at the time of data cut-off were censored on the last date of treatment. Patients who discontinued a line of therapy for a reason other than disease progression but who subsequently die prior to the receipt of any other therapy were considered an event on the date of death. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1): Progressive disease (PD): at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), or unequivocal progression of existing non-target lesions, or the appearance of one or more new lesions. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 millimeter (mm). | All patients who initiated index therapy (i.e., afatinib in any line; other systemic therapy among those without any history of afatinib) between 01 January 2017 and 31 March 2020. | Posted | Median | 95% Confidence Interval | months | From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days. |
| ||||||||||||||||||||||||||||||||||||
| Primary | Time on Treatment (TOT) | TOT was defined as time from initiation of a line of therapy until discontinuation for any reason. Patients on therapy at the time of data cut-off were censored on the last date of treatment. | All patients who initiated index therapy (i.e., afatinib in any line; other systemic therapy among those without any history of afatinib) between 01 January 2017 and 31 March 2020. | Posted | Median | 95% Confidence Interval | months | From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days. |
| ||||||||||||||||||||||||||||||||||||
| Primary | Time to Progression (TTP) | TTP was defined as time from initiation of a line of therapy until discontinuation due to disease progression. Patients on therapy or those who discontinued due to a reason other than disease progression were censored on the last date of treatment. | All patients who initiated index therapy (i.e., afatinib in any line; other systemic therapy among those without any history of afatinib) between 01 January 2017 and 31 March 2020. | Posted | Median | 95% Confidence Interval | months | From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days. |
| ||||||||||||||||||||||||||||||||||||
| Primary | Overall Survival (OS) | OS was defined as time from initiation of any therapy in the metastatic setting until death. Patients alive at the time of data cut-off were censored on the last date the patient was seen by the provider/clinic. | All patients who initiated index therapy (i.e., afatinib in any line; other systemic therapy among those without any history of afatinib) between 01 January 2017 and 31 March 2020. | Posted | Median | 95% Confidence Interval | months | From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days. |
| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Patients Who Experienced Any ADRs During Index Treatment Line | Number of patients who experienced any averse drug reactions (ADRs) during index treatment line is reported. An ADR was defined as a response to a medicinal product which is noxious and unintended. Response in this context means that a causal relationship between a medicinal product and an adverse event (AE) is at least a reasonable possibility. | All patients who initiated index therapy (i.e., afatinib in any line; other systemic therapy among those without any history of afatinib) between 01 January 2017 and 31 March 2020. | Posted | Count of Participants | Participants | From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e. 11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days. |
|
From the index date (i.e., anytime between 01-January-2017 and 31-March-2020) until data collection (i.e.11-Nov-2020 to 20-Jan-2021), up to 4 years and 19 days.
All patients who initiated index therapy (i.e., afatinib in any line; other systemic therapy among those without any history of afatinib) between 01 January 2017 and 31 March 2020.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Afatinib Patients | Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up). | 1 | 72 | 0 | 72 | 2 | 72 |
| EG001 | All Non-afatinib (Other Systemic Therapies) | Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up). | 3 | 38 | 4 | 38 | 3 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 24.0 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Dec 14, 2022 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077716 | Afatinib |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Midwest |
|
| South |
|
| West |
|
| Second line therapy (2L) |
|
| ≥ third line therapy (3L+) |
|
| 2+ |
|
| Current smoker |
|
| Past history of smoking |
|
| Stage II |
|
| Stage III |
|
| Stage IV |
|
| Cardiovascular disease |
|
| Diabetes with chronic complications |
|
| Chronic pulmonary disease |
|
| Depression |
|
| None of the above |
|
| Foundation One |
|
| Other |
|
| Specialty gene testing lab |
|
| Tempus |
|
| Unknown |
|
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up).
| OG002 | First Line Afatinib Patients | Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib as a first line (1L) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up). |
| OG003 | First Line Non-afatinib Patients | Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up). |
|
|
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up).
| OG002 | First Line Afatinib Patients | Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up). |
| OG003 | First Line Non-afatinib Patients | Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up). |
|
|
Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up). |
| OG002 | First Line Afatinib Patients | Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up). |
| OG003 | First Line Non-afatinib Patients | Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up). |
|
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| OG001 | All Non-afatinib (Other Systemic Therapies) | Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib (in any line of therapy) for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up). |
| OG002 | First Line Afatinib Patients | Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up). |
| OG003 | First Line Non-afatinib Patients | Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up). |
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| OG002 | First Line Afatinib Patients | Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up). |
| OG003 | First Line Non-afatinib Patients | Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up). |
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| OG002 | First Line Afatinib Patients | Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up). |
| OG003 | First Line Non-afatinib Patients | Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib as a first line of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up). |
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| OG002 | First Line Afatinib Patients | Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up). |
| OG003 | First Line Non-afatinib Patients | Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up). |
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| OG002 | First Line Afatinib Patients | Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of afatinib (unless deceased prior to 3 months of follow-up). |
| OG003 | First Line Non-afatinib Patients | Patients with a confirmed Neuregulin-1 (NRG1) gene fusion in any solid tumor, who initiated treatment with other systemic therapies than afatinib as a first line (IL) of therapy for treatment of a solid tumor with NRG1 gene fusion on or after 01-January-2017 through 31-March-2020 and followed up for ≥3 months after initiation of other systemic therapies than afatinib (unless deceased prior to 3 months of follow-up). |
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