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| ID | Type | Description | Link |
|---|---|---|---|
| IDEALKROS | Other Identifier | Alias Study Number | |
| IDEALK | Other Identifier | Alias Study Number |
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Prospective observational study to IDEntify patients with advanced/metastatic NSCLC and ALK and ROS1 translocation and to establish their therapeutic management (IDEALK&ROS)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine clinical practice group (NSCLC ALK+, ROS1) | Patients diagnosed and treated following routine clinical practice, for their NSCLC ALK+ or ROS1 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Crizotinib | Drug | Treatment with crizotinib following routine clinical practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | ECOG quality of life score is a rating of a participant's disease status, daily living activities and quality of life, where 0: fully active, 1: restricted in physically strenuous activity, 2: ambulatory and capable of self-care but unable to work, 3: capable only of limited self-care , 4: completely disabled; cannot carry on any self-care; totally confined to bed or chair, 5: dead. Higher scores indicated more severe disease, difficulty in performing daily activity and poor quality of life. Number of participants classified according to ECOG quality of life scores were reported in this outcome measure. | At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease) |
| Number of Participants Classified According to the Origin of Tumor Sample | Number of participants classified according to the origin of tumor sample (primary tumor or metastasis) were reported in this outcome measure. | At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis) |
| Number of Participants Classified According to Type of Sample Collected for Tumor Analysis | Number of participants classified according to the type of sample collected (biopsy, cell block or cytology) were reported in this outcome measure. | At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis) |
| Number of Participants Classified According to Histological Subtype of Tumor | Number of participants classified according to the histological subtype (adenocarcinoma, squamous, large cell, not otherwise specified [NOS], other) were reported in this outcome measure. |
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Inclusion Criteria:
For ALK Incidence substudy
For the ROS1 treatment sub-study (retrospective only):
Exclusion Criteria:
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NSCLC Patients, ALK +translocation confirmed, ROS1+translocation confirmed
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínico Univ. de Santiago de Compostela | Santiago de Compostela | A Coruña | 15076 | Spain | ||
| Hospital Virgen de los Lirios |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36162227 | Derived | Aguado de la Rosa C, Cruz Castellanos P, Lazaro-Quintela M, Domine M, Vazquez Estevez S, Lopez-Vivanco G, Firvida Perez JL, Alonso Romero JL, Ferrera Delgado L, Garcia Giron C, Diz Tain P, Alvarez Alvarez R, Mut Sanchis P, Fernandez Canton I, Manrique Abos I, Martinez Aguillo M, Gomez-Aldaravi Gutierrez L, Ortega Granados AL, Alvarez Cabellos R, Garcia Sebastian A, Garcia Sifuentes LF, Reguart N. Identification of ALK-positive patients with advanced NSCLC and real-world clinical experience with crizotinib in Spain (IDEALK study). Lung Cancer. 2022 Nov;173:83-93. doi: 10.1016/j.lungcan.2022.09.010. Epub 2022 Sep 19. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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Participants with advanced/metastatic non-small cell lung cancer (NSCLC) were recruited in this multicentre, observational post-authorisation study. Participants were included in 3 sub-studies: ALK incidence, ALK treatment and ROS1 treatment sub-study. A total of 692 participants were enrolled in the study (ALK incidence sub-study= 572, ALK treatment sub-study=70 participants excluding 21 participants who were included from ALK incidence sub-study and ROS1 sub-study: 50).
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| ID | Title | Description |
|---|---|---|
| FG000 | ALK Incidence Sub-study | All participants with advanced/metastatic Non-Small Cell Lung Cancer (NSCLC) diagnosed at the hospital and who underwent Anaplastic Lymphoma Kinase (ALK) translocation molecular testing subsequently were included in the incidence sub-study. |
| FG001 | ALK Treatment Sub-study |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| ALK Incidence Sub-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 18, 2020 | May 3, 2023 |
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| At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of diagnosis of ALK and ROS1 metastatic disease) |
| Number of Participants Classified According to Stage of Tumor: ALK Treatment Sub-study and ROS1 Treatment Sub-study | Tumor Node Metastasis (TNM): based on tumor size, metastasis to nearby lymph nodes (LN), or distant metastasis. Stages were: stage IIIA (T0N2M0, T1N2M0,T2N3M0, T3N1 or N2M0), stage IIIB (T4 any NM0, any TN3M0), stage IV (any T any NM1), where T0 = early form of tumor, T1 = less than (<) 2 centimeter (cm), T2 = 2-5 cm, T3 = greater than (>) 5 cm, T4 = large sized, N0 = not spread to lymph nodes (LN), N1 = spread to 1 to 3 LN, N2 = spread to 4 to 9 LN, N3 = spread >10 axillary LN, M0 = no metastasis, M1 = metastasis. The number of participants classified according to stages of tumor (Stage IIIA, IIIB and IV) were reported in this outcome measure. | At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis of metastatic disease) |
| Number of Participants Classified According to Molecular Alterations in Tumor: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Number of participants classified according to molecular alterations (PD-L1+: programmed death-ligand 1 positive, MET+: mesenchymal epithelial transition factor receptor positive, TP53+: tumor protein 53 positive, AKT: serine/threonine-protein kinase) in tumors were reported in this outcome measure. | At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease) |
| Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Number of participants classified according to the location of metastases were reported in this outcome measure. One participant may have more than one site of metastases. | At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease) |
| Number of Participants Categorized According to Number of Treatments Prior to Crizotinib: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Number of participants classified according to number of treatments (1 or 2) prior to crizotinib were reported in this outcome measure. | At baseline (for ALK treatment sub-study: after initial diagnosis of ALK metastatic disease; for ROS1 treatment sub-study: after initial diagnosis of ROS1 metastatic disease) |
| Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Number of participants with treatment response as complete response (CR): disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 millimeter [mm] short axis), partial response (PR): at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), progressive disease (PD): at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were reported in this outcome measure. | From date of inclusion until last date of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months) |
| Number of Participants Classified According to Survival Data: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | The number of participants classified as dead or alive were reported in this outcome measure. | From date of inclusion until last date of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months) |
| Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | QLQ-C30: 30 item questionnaire consisted of a global health (GH) score, 5 functional domains, 8 symptom scales and single item about financial difficulties. All items were graded by severity experienced during previous week and used a 4-point-scale (1: not at all, 2: a little, 3: quite a bit, 4: very much). The scores were converted to health-related quality of life (HRQoL) scale ranging from 0 - 100. Higher GH and functional domain scores indicated better function and lower scores in symptom scales and single item indicated more severity. Positive changes from baseline indicated improvement and negative changes from baseline indicated worsening for GH and functional domains. Negative changes from baseline indicated improvement and higher levels of functioning and positive changes from baseline indicated worsening for symptom scale and single item. Stable indicated that the symptoms were neither improving nor worsening. | Baseline, End (day 28) of Cycles 1 and 3, and end of treatment (up to approximately 15.2 months) |
| Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer & treatment side effects typical of treatment with chemotherapy and radiotherapy. It comprised of multi-item scale and single-item scale for symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, & medicine for pain). Response range - 1: Not at all to 4: Very much. The scores were converted to a HRQoL scale ranging from 0 - 100 where, higher scores = greater level of symptoms. Negative changes from baseline indicated improvement and positive changes from baseline indicated worsening. Stable indicated that the symptoms were neither improving nor deteriorating. | Baseline, End (day 28) of Cycles 1 and 3, and end of treatment (up to approximately 15.2 months) |
| Percentage of Participants With Anaplastic Lymphoma Kinase Positive Translocations: ALK Incidence Sub-Study | The percentage of participants with ALK positive translocations were reported in this outcome measure. | At baseline (after initial diagnosis of lung cancer and until end of recruitment of ALK incidence sub study) |
| Progression-Free Survival (PFS): ALK Treatment Sub-study and ROS1 Treatment Sub-Study | Progression-free survival (PFS) was defined as the period between the first day of treatment and the first day that progressive disease (PD) (at least a 20% increase [including an absolute increase of at least 5 mm] in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions) was observed according to response evaluation criteria in solid tumors (RECIST) criteria, or death. Participants who have not had an event at the time of the analysis of the study data were censored at the date of the last available follow-up. | From first day of treatment until date of progressive disease, death or censored, whichever was the earliest (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months) |
| Objective Response Rate (ORR): ALK Treatment Sub-study and ROS1 Treatment Sub-Study | ORR: percentage of participants who achieved CR : disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size(<10 mm short axis), or PR : at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Additionally, the participants with SD : neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. The participants were evaluated in accordance with RECIST criteria. | From first day of treatment until date of CR, PR or SD (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months) |
| Duration of Response (DOR): ALK Treatment Sub-study and ROS1 Sub-Study | Duration of response (DOR) in participants with PR or CR was defined as the interval from the date the best response was documented to the first date that progressive disease (at least a 20% increase [including an absolute increase of at least 5 mm] in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions) was observed. | From the date the best response was documented until the date of progressive disease (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months) |
| Overall Survival (OS): ALK Treatment Sub-study and ROS1 Treatment Sub-Study | Overall survival (OS) was defined as the period from the first day of treatment until death or censored up to the last date on which it was known that the participant was alive. | From first day of treatment until date of death or censored, whichever was earliest (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months) |
| Number of Participants With Adverse Events According to Seriousness: ALK Treatment Sub-study and ROS1 Treatment Sub-Study | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. SAE was defined as any untoward medical occurrence at any dose that: resulted in death, was life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required hospitalization or prolongation of existing hospitalization. The number of participants with non-SAEs and SAEs were reported in this outcome measure. | From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months) |
| Alcoy |
| Alicante |
| 03804 |
| Spain |
| Complejo Hospitalario de Jerez | Jerez de la Frontera | Cadiz | 11407 | Spain |
| Hospital Marqués de Valdecilla | Santander | Cantabria | 9008 | Spain |
| Hospital General Mancha Centro | Alcázar de San Juan | Ciudad REAL | 13600 | Spain |
| Hospital Universitario de Gran Canaria Dr. Negrin | Las Palmas de Gran Canaria | LAS Palmas | 35010 | Spain |
| Hospital Universitario de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital Universitario Cruces | Barakaldo | Vizcaia | 48903 | Spain |
| Hospital Universitario de Albacete | Albacete | 02006 | Spain |
| Hospital Universitario Clinic i Provincial | Barcelona | 08036 | Spain |
| Hospital Universitario de Burgos | Burgos | 09006 | Spain |
| Hospital Universitario Puerta del Mar, Cádiz | Cadiz | 11009 | Spain |
| Complejo Hospitalario de Jaen | Jaén | 23007 | Spain |
| Complejo Hospitalario Universitario Insular Materno-Infantil | Las Palmas de Gran Canaria | 35016 | Spain |
| Hospital Universitario de León | León | 24080 | Spain |
| Hospital Universitario San Pedro, Logroño | Logroño | 26006 | Spain |
| Hospital Universitario Lucus Augusti (HULA_ Lugo) | Lugo | 27003 | Spain |
| Hospital Universitario de La Princesa | Madrid | 28006 | Spain |
| Hospital Universitario Gregorio Marañón | Madrid | 28007 | Spain |
| Hospital Universitario Clinico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario Fundación Jimenez Diaz | Madrid | 28040 | Spain |
| H.U. La Paz | Madrid | 28046 | Spain |
| Hospital Regional Universitario Carlos Haya | Málaga | 29010 | Spain |
| Hospital Universitario Arrixaca | Murcia | 30120 | Spain |
| Complejo Hospitalario Universitario de Ourense (CHUOU) | Ourense | 32005 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | 33011 | Spain |
| HU Son Llatzer, Palma de Mallorca / Servicio de Oncología Médica | Palma de Mallorca | 07198 | Spain |
| Hospital Universitario de la Candelaria, Tenerife | Santa Cruz de Tenerife | 38010 | Spain |
| Hospital Universitario Virgen Macarena | Seville | 41009 | Spain |
| Hospital Virgen de La Salud | Toledo | 45004 | Spain |
| Hospital Universitario y Politecnico La Fe | Valencia | 46026 | Spain |
| Hospital Universitario de Vigo- Hospital Álvaro Cunqueiro / Servicio de Oncología Médica | Vigo | 36312 | Spain |
Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included. |
| FG002 | ROS1 Treatment Sub-study | Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included. |
| Full Analysis Set |
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| Safety Analysis Set |
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| COMPLETED |
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| NOT COMPLETED |
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| ALK Treatment Sub-study |
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| ROS1 Treatment Sub-study |
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Full Analysis Set: ALK incidence sub-study- analysis population included all participants who presented an evaluable test for ALK translocation. ALK treatment sub-study- analysis population included only those participants exclusive to ALK treatment sub-study with confirmed ALK-positive translocation & who received treatment with crizotinib. ROS1 treatment sub-study- analysis population included all participants who had confirmed ROS1 translocation and had received atleast 1 dose of crizotinib.
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| ID | Title | Description |
|---|---|---|
| BG000 | ALK Incidence Sub-study | All participants with advanced/metastatic Non-Small Cell Lung Cancer (NSCLC) diagnosed at the hospital and who underwent Anaplastic Lymphoma Kinase (ALK) translocation molecular testing subsequently were included in the incidence sub-study. |
| BG001 | ALK Treatment Sub-study | Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included. |
| BG002 | ROS1 Treatment Sub-study | Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and ethnicity were not collected. | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Number of Participants Classified According to Smoking Status | Number for participants classified according to smoking status (non-smoker, former smoker, smoker) were reported in this baseline characteristic. | Count of Participants | Participants |
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| Previous Relevant Medical History: ALK Treatment Sub-study and ROS1 Sub-study | Number of participants according to previous medical history were reported in this baseline characteristic. One participant may have more than one previous medical history. | Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. | Count of Participants | Participants |
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| 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 | |||||||||||||||||||||||||
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| Primary | Eastern Cooperative Oncology Group (ECOG) Quality of Life Score: ALK Treatment and ROS1 Sub-study Only | ECOG quality of life score is a rating of a participant's disease status, daily living activities and quality of life, where 0: fully active, 1: restricted in physically strenuous activity, 2: ambulatory and capable of self-care but unable to work, 3: capable only of limited self-care , 4: completely disabled; cannot carry on any self-care; totally confined to bed or chair, 5: dead. Higher scores indicated more severe disease, difficulty in performing daily activity and poor quality of life. Number of participants classified according to ECOG quality of life scores were reported in this outcome measure. | ALK treatment sub-study: analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. ROS1 treatment sub-study: analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease) |
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| Primary | Number of Participants Classified According to the Origin of Tumor Sample | Number of participants classified according to the origin of tumor sample (primary tumor or metastasis) were reported in this outcome measure. | For ALK incidence sub-study, analysis population included all participants who presented an evaluable test for ALK translocation. For ALK treatment sub-study, analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. For ROS1 treatment sub-study, analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. | Posted | Count of Participants | Participants | At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis) |
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| Primary | Number of Participants Classified According to Type of Sample Collected for Tumor Analysis | Number of participants classified according to the type of sample collected (biopsy, cell block or cytology) were reported in this outcome measure. | For ALK incidence sub-study, analysis population included all participants who presented an evaluable test for ALK translocation. For ALK treatment sub-study, analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. For ROS1 treatment sub-study, analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. | Posted | Count of Participants | Participants | At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis) |
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| Primary | Number of Participants Classified According to Histological Subtype of Tumor | Number of participants classified according to the histological subtype (adenocarcinoma, squamous, large cell, not otherwise specified [NOS], other) were reported in this outcome measure. | For ALK incidence sub-study, analysis population included all participants who presented an evaluable test for ALK translocation. For ALK treatment sub-study, analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. For ROS1 treatment sub-study, analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. | Posted | Count of Participants | Participants | At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of diagnosis of ALK and ROS1 metastatic disease) |
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| Primary | Number of Participants Classified According to Stage of Tumor: ALK Treatment Sub-study and ROS1 Treatment Sub-study | Tumor Node Metastasis (TNM): based on tumor size, metastasis to nearby lymph nodes (LN), or distant metastasis. Stages were: stage IIIA (T0N2M0, T1N2M0,T2N3M0, T3N1 or N2M0), stage IIIB (T4 any NM0, any TN3M0), stage IV (any T any NM1), where T0 = early form of tumor, T1 = less than (<) 2 centimeter (cm), T2 = 2-5 cm, T3 = greater than (>) 5 cm, T4 = large sized, N0 = not spread to lymph nodes (LN), N1 = spread to 1 to 3 LN, N2 = spread to 4 to 9 LN, N3 = spread >10 axillary LN, M0 = no metastasis, M1 = metastasis. The number of participants classified according to stages of tumor (Stage IIIA, IIIB and IV) were reported in this outcome measure. | ALK treatment sub-study: analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. ROS1 treatment sub-study: analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only. | Posted | Count of Participants | Participants | At baseline (for ALK incidence sub-study: at the beginning of initial diagnosis of lung cancer; for ROS1 and ALK treatment sub-study: at the beginning of ALK and ROS1 initial diagnosis of metastatic disease) |
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| Primary | Number of Participants Classified According to Molecular Alterations in Tumor: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Number of participants classified according to molecular alterations (PD-L1+: programmed death-ligand 1 positive, MET+: mesenchymal epithelial transition factor receptor positive, TP53+: tumor protein 53 positive, AKT: serine/threonine-protein kinase) in tumors were reported in this outcome measure. | ALK treatment sub-study: all participants with confirmed ALK-positive translocation and who received treatment with crizotinib.ROS1 treatment sub-study: all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib.Here,'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only. | Posted | Count of Participants | Participants | At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease) |
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| Primary | Number of Participants Classified According to Location of Metastases: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Number of participants classified according to the location of metastases were reported in this outcome measure. One participant may have more than one site of metastases. | ALK treatment sub-study: analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. ROS1 treatment sub-study: analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only. | Posted | Count of Participants | Participants | At baseline (for ALK treatment sub-study: at the beginning of diagnosis of ALK; for ROS1 treatment sub-study: at the beginning of diagnosis of ROS1 metastatic disease) |
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| Primary | Number of Participants Categorized According to Number of Treatments Prior to Crizotinib: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Number of participants classified according to number of treatments (1 or 2) prior to crizotinib were reported in this outcome measure. | ALK treatment sub-study: all participants with confirmed ALK-positive translocation and who received treatment with crizotinib.ROS1 treatment sub-study: all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib.Here,'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only. | Posted | Count of Participants | Participants | At baseline (for ALK treatment sub-study: after initial diagnosis of ALK metastatic disease; for ROS1 treatment sub-study: after initial diagnosis of ROS1 metastatic disease) |
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| Primary | Number of Participants According to Treatment Response: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | Number of participants with treatment response as complete response (CR): disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size (<10 millimeter [mm] short axis), partial response (PR): at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), progressive disease (PD): at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were reported in this outcome measure. | ALK treatment sub-study: analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. ROS1 treatment sub-study: analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only. | Posted | Count of Participants | Participants | From date of inclusion until last date of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months) |
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| Primary | Number of Participants Classified According to Survival Data: ALK Treatment Sub-Study and ROS1 Treatment Sub-Study | The number of participants classified as dead or alive were reported in this outcome measure. | ALK treatment sub-study: analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. ROS1 treatment sub-study: analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only. | Posted | Count of Participants | Participants | From date of inclusion until last date of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months) |
| |||||||||||||||||||||||||||||||||
| Primary | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire (EORTC QLQ-C30) Scores: ALK Treatment Sub-study | QLQ-C30: 30 item questionnaire consisted of a global health (GH) score, 5 functional domains, 8 symptom scales and single item about financial difficulties. All items were graded by severity experienced during previous week and used a 4-point-scale (1: not at all, 2: a little, 3: quite a bit, 4: very much). The scores were converted to health-related quality of life (HRQoL) scale ranging from 0 - 100. Higher GH and functional domain scores indicated better function and lower scores in symptom scales and single item indicated more severity. Positive changes from baseline indicated improvement and negative changes from baseline indicated worsening for GH and functional domains. Negative changes from baseline indicated improvement and higher levels of functioning and positive changes from baseline indicated worsening for symptom scale and single item. Stable indicated that the symptoms were neither improving nor worsening. | Analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. This outcome measure was planned to be analyzed in ALK treatment sub-study only. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' indicates number of participants evaluable at specified timepoints. | Posted | Count of Participants | Participants | Baseline, End (day 28) of Cycles 1 and 3, and end of treatment (up to approximately 15.2 months) |
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| Primary | Percentage of Participants With European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13) Scores: ALK Treatment Sub-study | QLQ-LC13 consisted of 13 questions relating to disease symptoms specific to lung cancer & treatment side effects typical of treatment with chemotherapy and radiotherapy. It comprised of multi-item scale and single-item scale for symptoms and side effects (coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm pain, other pain, & medicine for pain). Response range - 1: Not at all to 4: Very much. The scores were converted to a HRQoL scale ranging from 0 - 100 where, higher scores = greater level of symptoms. Negative changes from baseline indicated improvement and positive changes from baseline indicated worsening. Stable indicated that the symptoms were neither improving nor deteriorating. | Analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study only. Here, 'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' indicates number of participants evaluable at specified timepoints. | Posted | Count of Participants | Participants | Baseline, End (day 28) of Cycles 1 and 3, and end of treatment (up to approximately 15.2 months) |
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| Primary | Percentage of Participants With Anaplastic Lymphoma Kinase Positive Translocations: ALK Incidence Sub-Study | The percentage of participants with ALK positive translocations were reported in this outcome measure. | Analysis population included all participants presented an evaluable test for ALK translocation. This outcome measure was planned to be analyzed for ALK incidence sub-study only. | Posted | Count of Participants | Participants | At baseline (after initial diagnosis of lung cancer and until end of recruitment of ALK incidence sub study) |
|
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| Primary | Progression-Free Survival (PFS): ALK Treatment Sub-study and ROS1 Treatment Sub-Study | Progression-free survival (PFS) was defined as the period between the first day of treatment and the first day that progressive disease (PD) (at least a 20% increase [including an absolute increase of at least 5 mm] in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions) was observed according to response evaluation criteria in solid tumors (RECIST) criteria, or death. Participants who have not had an event at the time of the analysis of the study data were censored at the date of the last available follow-up. | For ALK treatment sub-study, analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. For ROS1 treatment sub-study, analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only. | Posted | Median | 95% Confidence Interval | Months | From first day of treatment until date of progressive disease, death or censored, whichever was the earliest (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months) |
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| Primary | Objective Response Rate (ORR): ALK Treatment Sub-study and ROS1 Treatment Sub-Study | ORR: percentage of participants who achieved CR : disappearance of all target and non-target lesions and normalization of tumor marker level, all lymph nodes must be non-pathological in size(<10 mm short axis), or PR : at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits. Additionally, the participants with SD : neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, PD: at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions were evaluated. The participants were evaluated in accordance with RECIST criteria. | ALK treatment sub-study: all participants with confirmed ALK-positive translocation and who received treatment with crizotinib.ROS1 treatment sub-study: all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib.Here,'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only. | Posted | Number | Percentage of participants | From first day of treatment until date of CR, PR or SD (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months) |
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| Primary | Duration of Response (DOR): ALK Treatment Sub-study and ROS1 Sub-Study | Duration of response (DOR) in participants with PR or CR was defined as the interval from the date the best response was documented to the first date that progressive disease (at least a 20% increase [including an absolute increase of at least 5 mm] in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions) was observed. | ALK treatment sub-study: all participants with confirmed ALK-positive translocation and who received treatment with crizotinib.ROS1 treatment sub-study: all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib.Here,'Overall Number of Participants Analyzed' signifies number of participants evaluable for this outcome measure.This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only. | Posted | Median | Full Range | Months | From the date the best response was documented until the date of progressive disease (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months) |
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| Primary | Overall Survival (OS): ALK Treatment Sub-study and ROS1 Treatment Sub-Study | Overall survival (OS) was defined as the period from the first day of treatment until death or censored up to the last date on which it was known that the participant was alive. | For ALK treatment sub-study, analysis population included all participants with confirmed ALK-positive translocation and who received treatment with crizotinib. For ROS1 treatment sub-study, analysis population included all participants who had confirmed ROS1 translocation and had received at least 1 dose of crizotinib. This outcome measure was planned to be analyzed for ALK treatment sub-study and ROS1 treatment sub-study only. | Posted | Median | 95% Confidence Interval | Months | From first day of treatment until date of death or censored, whichever was earliest (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months) |
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| Primary | Number of Participants With Adverse Events According to Seriousness: ALK Treatment Sub-study and ROS1 Treatment Sub-Study | An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. SAE was defined as any untoward medical occurrence at any dose that: resulted in death, was life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was important medical event; required hospitalization or prolongation of existing hospitalization. The number of participants with non-SAEs and SAEs were reported in this outcome measure. | Safety population included all participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all the study screening criteria and had received at least one dose of treatment with crizotinib. | Posted | Count of Participants | Participants | From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months) |
|
From start of study treatment until end of follow-up (ALK treatment sub-study: maximum of 96.5 months and ROS1 treatment sub-study: maximum of 46.6 months)
An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both serious and non-serious event. Safety population: analysis included participants with advanced/metastatic NSCLC with confirmed ALK/ROS1 positive translocation who met all study screening criteria and had at least 1 dose of crizotinib treatment. Data was not collected for ALK Incidence sub-study as the pre-defined criteria for safety collection did not meet.
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 | ALK Treatment Sub-study | Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included. | 38 | 91 | 25 | 91 | 54 | 91 |
| EG001 | ROS1 Treatment Sub-study | Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included. | 25 | 50 | 9 | 50 | 33 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transaminases increased | Investigations | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Oesophageal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Pain | General disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Localised oedema | General disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| General deterioration of physical condition | General disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Post-intervention complication | Injury, poisoning and procedural complications | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated alanine aminotransferase | Investigations | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Elevated amylase | Investigations | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Elevated aspartate aminotransferase | Investigations | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Increased blood alkaline phosphatase | Investigations | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Elevated Gamma glutamyl transferase | Investigations | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Increased QT Interval electrocardiography | Investigations | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Elevated Transaminases | Investigations | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Decreased weight | Investigations | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Oesophagic candidiasis | Infections and infestations | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Candidiasis infection | Infections and infestations | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Tumor progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Skin toxicity | Skin and subcutaneous tissue disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Rash pruritus | Skin and subcutaneous tissue disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Folliculitis | Skin and subcutaneous tissue disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Photosensitivity reaction | Skin and subcutaneous tissue disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Amenorrhea | Reproductive system and breast disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Hypophosphatemia | Metabolism and nutrition disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Trigeminal neuralgia | Nervous system disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Peripheric neurophathy | Nervous system disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Upper abdominal pain | Gastrointestinal disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Enteritis | Gastrointestinal disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Nauseous | Gastrointestinal disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Odynophagia | Gastrointestinal disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Gastrointestinal toxicity | Gastrointestinal disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Oedema | General disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Hot flushes | General disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Vision disorders | Eye disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Photopsia | Eye disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Blepharitis/Meibomytis | Eye disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Dry eye | Eye disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Kidney impairment | Renal and urinary disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Effort dyspnea | Respiratory, thoracic and mediastinal disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | ALK:v24.0;ROS1:v25.0 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 25, 2021 | May 3, 2023 | 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 |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077547 | Crizotinib |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D000631 | Aminopyridines |
| D011725 | Pyridines |
Not provided
Not provided
|
|
|
|
|
| Neoplasm diseases |
|
|
| Gastrointestinal disorders |
|
|
| Pulmonary diseases |
|
|
| Surgery |
|
|
| Other |
|
|
| 2 |
|
| 3 |
|
| 4 |
|
| 5 |
|
| OG002 | ROS1 Treatment Sub-study | Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included. |
|
|
| OG002 | ROS1 Treatment Sub-study | Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included. |
|
|
| OG002 | ROS1 Treatment Sub-study | Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included. |
|
|
| OG001 | ROS1 Treatment Sub-study | Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included. |
|
|
|
|
|
|
|
|
Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included.
| OG001 | ROS1 Treatment Sub-study | Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included. |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included.
|
|
|
|
|
| OG001 | ROS1 Treatment Sub-study | Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included. |
|
|
Participants with advanced/metastatic NSCLC with confirmed ALK-positive translocation and who were treated with crizotinib in routine clinical practice retrospectively from January 2014 or prospectively during the study were included.
| OG001 | ROS1 Treatment Sub-study | Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included. |
|
|
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included. |
|
|
|
|
Participants with advanced/metastatic NSCLC with confirmed ROS1-positive translocation and who were treated with crizotinib in routine clinical practice on or after 08-Feb-2017 were included.
|
|