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This is a non-interventional, multi-country, multi-site study based on existing data from medical records of patients treated with Gi(l)otrif® as part of the routine treatment according to the approved label. Data from real-world will help to understand if dose modifications are done similar as in LUX-Lung 3 trial and if the outcome on safety and effectiveness are as in trial settings. Furthermore, data on modified starting doses, the underlying reasons and effects on safety and outcome are needed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non small cell lung cancer (NSCLC) | patients with Epidermal growth factor receptor (EGFR) mutation (common mutations), TKI-naïve advanced non small cell lung cancer (NSCLC), treated with Gi(l)otrif® as the first-line treatment for NSCLC within the approved label |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With Adverse Drug Reactions (ADR) by Severity Class. | An adverse drug reaction (ADR) is defined as a response to a medicinal product which is noxious and unintended. Grade 1, Grade 2, Grade 3 and Grade 4 ADR severity classes were considered for assessment of this outcome. | From signing the informed consent onwards until the end of the study, up to 104 weeks. |
| Time on Treatment With Gi(l)Otrif® | Time on treatment with Gi(l)otrif® in real-world setting has been calculated in this assessment. Time on treatment refers to time to treatment failure with Gi(l)otrif® | From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks. |
| Time to Progression With Gi(l)Otrif® | Time to progression was calculated from the date of first dose of Gi(l)otrif® treatment to the earliest date of documented progression (clinical, radiographic or both clinical/radiographic progression) or tumour-related death, whatever occurred first. | From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients With a Modified Starting Dose of Gi(l)Otrif® | Percentage of patients with a modified starting dose that is dose other than the recommended 40 mg daily of Gi(l)otrif® has been calculated to assess this outcome measure. | From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks. |
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Inclusion criteria:
Exclusion criteria:
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NSCLC patients
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montefiore Medical Center | The Bronx | New York | 10461 | United States | ||
| Levine Cancer Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30642537 | Derived | Halmos B, Tan EH, Soo RA, Cadranel J, Lee MK, Foucher P, Hsia TC, Hochmair M, Griesinger F, Hida T, Kim E, Melosky B, Marten A, Carcereny E. Impact of afatinib dose modification on safety and effectiveness in patients with EGFR mutation-positive advanced NSCLC: Results from a global real-world study (RealGiDo). Lung Cancer. 2019 Jan;127:103-111. doi: 10.1016/j.lungcan.2018.10.028. Epub 2018 Nov 2. |
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All patients were screened for eligibility to participate in the study. Patients attended specialist sites which would then ensure that all patients met all inclusion/exclusion criteria. Patients were not to be entered to study if any of the specific entry criteria were violated.
This is a non-interventional, multi-country, multi-site study based on existing data from medical records of patients treated with Gi(l)otrif® tablet once daily as indicated in the approved labels. Between December 2016 and October 2017, 231 patients were screened for study participation and 228 patients were treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Gi(l)Otrif ≥ 40 mg | Patients were orally treated with starting dose of greater than or equal to 40 mg Gi(l)otrif tablet once daily. |
| FG001 | Gi(l)Otrif ≤ 30 mg | Patients were orally treated with starting dose of less than or equal to 30 mg Gi(l)otrif tablet once daily. |
| 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 | Yes | No | No | Study Protocol | Mar 1, 2016 | Sep 11, 2018 |
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| Percentage of Patients With Reasons for Modified Starting Dose of Gi(l)Otrif® |
Different reasons for starting dose with modified dose that is dose other than recommended 40 mg once daily. |
| From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks. |
| Charlotte |
| North Carolina |
| 28201 |
| United States |
| SMZ Baumgartner Hoehe Otto Wagner Spital | Vienna | 1140 | Austria |
| BC Cancer Agency - Vancouver | Vancouver | British Columbia | V5Z 4E6 | Canada |
| HOP Jean Minjoz | Besançon | 25030 | France |
| HOP Dijon, Cardio-Pneumo, Dijon | Dijon | 21079 | France |
| HOP Européen G. Pompidou | Paris | 75908 | France |
| HOP Tenon | Paris | 75970 | France |
| Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH | Essen | 45147 | Germany |
| Klinikum Nürnberg | Nuremberg | 90419 | Germany |
| Pius-Hospital, Oldenburg | Oldenburg | 26121 | Germany |
| Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo | Alessandria | 15121 | Italy |
| Azienda Ospedaliera Vito Fazzi | Lecce | 73100 | Italy |
| Aichi Cancer Center Hospital | Aichi, Nagoya | 464-8681 | Japan |
| Kurashiki Central Hospital | Okayama, Kurashiki | 710-8602 | Japan |
| Centro Medico ABC | Mexico City | 01120 | Mexico |
| Organización para Cuidado Integral en OncologÃa S.A de C.V | Monterrey | 64060 | Mexico |
| Unidad de Cancerologia | Zapopan | 45050 | Mexico |
| Medical Practice,Bogdan Zurawski,Private Practice,Bydgoszcz | Bydgoszcz | 85796 | Poland |
| Grzegorz Czyzewicz Specialised Medical Practice, Cracow | Cracow | 31331 | Poland |
| Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland | Poznan | 60-569 | Poland |
| National University Hospital | Singapore | 119228 | Singapore |
| National Cancer Centre | Singapore | 169610 | Singapore |
| Yeungnam University Medical Center | Daegu | 705-703 | South Korea |
| Chonbuk National University Hospital | Jeonju | 54907 | South Korea |
| Pusan National Univ. Hosp | Pusan | 49241 | South Korea |
| Hospital Germans Trias i Pujol | Badalona (Barcelona) | 08916 | Spain |
| Hospital La Princesa | Madrid | 28006 | Spain |
| China Medical University Hospital | Taichung | 40447 | Taiwan |
| On Treatment at Study Completion |
|
| COMPLETED |
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| NOT COMPLETED |
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Full analysis set (FAS): All registered patients with informed consent (as applicable with local regulations) and at least one administration of Gi(l)otrif®.
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| ID | Title | Description |
|---|---|---|
| BG000 | Gi(l)Otrif ≥ 40 mg | Patients were orally treated with starting dose of greater than or equal to 40 mg Gi(l)otrif tablet once daily. |
| BG001 | Gi(l)Otrif ≤ 30 mg | Patients were orally treated with starting dose of less than or equal to 30 mg Gi(l)otrif tablet once daily. |
| 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 of all patients included in the trial | FAS | Mean | Standard Deviation | Years |
| |||||||||||||
| Sex: Female, Male | Gender distribution of all patients included in the trial. | FAS | Count of Participants | Participants |
| ||||||||||||||
| Ethnicity (NIH/OMB) | Ethnicity of all patients included in the trial. | FAS | Count of Participants | Participants |
| ||||||||||||||
| Race (NIH/OMB) | Race of all patients included in the trial. | FAS | 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 | Percentage of Patients With Adverse Drug Reactions (ADR) by Severity Class. | An adverse drug reaction (ADR) is defined as a response to a medicinal product which is noxious and unintended. Grade 1, Grade 2, Grade 3 and Grade 4 ADR severity classes were considered for assessment of this outcome. | Full Analysis set (FAS): All registered patients with informed consent (as applicable with local regulations) and at least one administration of Gi(l)otrif®. | Posted | Number | Percentage of patients (%) | From signing the informed consent onwards until the end of the study, up to 104 weeks. |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Time on Treatment With Gi(l)Otrif® | Time on treatment with Gi(l)otrif® in real-world setting has been calculated in this assessment. Time on treatment refers to time to treatment failure with Gi(l)otrif® | FAS | Posted | Median | 95% Confidence Interval | Months | From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks. |
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Time to Progression With Gi(l)Otrif® | Time to progression was calculated from the date of first dose of Gi(l)otrif® treatment to the earliest date of documented progression (clinical, radiographic or both clinical/radiographic progression) or tumour-related death, whatever occurred first. | FAS | Posted | Median | 95% Confidence Interval | Months | From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks. |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With a Modified Starting Dose of Gi(l)Otrif® | Percentage of patients with a modified starting dose that is dose other than the recommended 40 mg daily of Gi(l)otrif® has been calculated to assess this outcome measure. | FAS | Posted | Number | Percentage of patients (%) | From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks. |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Patients With Reasons for Modified Starting Dose of Gi(l)Otrif® | Different reasons for starting dose with modified dose that is dose other than recommended 40 mg once daily. | FAS | Posted | Number | Percentage of patients (%) | From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks. |
|
|
From signing the informed consent onwards until the end of the study, up to 104 weeks.
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Full Analysis set (FAS): All registered patients with informed consent (as applicable with local regulations) and at least one administration of Gi(l) otrif® was used for this assessment. This was a single-arm retrospective analysis.
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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 | Gi(l)Otrif ≥ 40 mg | Patients were orally treated with starting dose of greater than or equal to 40 mg Gi(l)otrif tablet once daily. | 8 | 157 | 11 | 157 | 147 | 157 |
| EG001 | Gi(l)Otrif ≤ 30 mg | Patients were orally treated with starting dose of less than or equal to 30 mg Gi(l)otrif tablet once daily. | 0 | 71 | 7 | 71 | 68 | 71 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pancreatitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Embolism | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
| |
| Nail ridging | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
Due to non-interventional character there were no predefined examinations, retro- and prospective data could be collected, bias regarding AE documentation, participation of patients on treatment was limited due to one exclusion criterion
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 |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 17, 2018 | Sep 11, 2018 | SAP_001.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 |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Grade 3 |
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| Grade 4 |
|
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