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| ID | Type | Description | Link |
|---|---|---|---|
| NCT06282991 | Registry Identifier | ClinicalTrials.gov |
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The purpose of this study is to learn about lorlatinib for the possible treatment of lung cancer which could not be controlled.
This study is seeking participants who:
All participants in this study had received lorlatinib. Lorlatinib is a tablet that is taken by mouth at home. They continued to take dacomitinib until their cancer was no longer responding. The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective.
Non-small cell lung cancer (NSCLC; 80-85% of all lung cancers) remains the most common cause of cancer-related mortality globally, most often diagnosed in advanced stages. Targeted drugs are currently the most often used therapies for advanced NSCLC patients that harbor molecular alterations, including the echinoderm microtubule-associated protein like 4 (EML4)-anaplastic lymphoma kinase (ALK) translocation. For ALK-positive NSCLC patients, crizotinib, ceritinib, alectinib, and brigatinib, are the first- and second-generation tyrosine kinase inhibitors (TKIs). Although the benefit of them has been demonstrated in series of pivotal clinical trials, most patients who initially derive the benefit latterly develop resistance due to secondary mutations. Lorlatinib, a third-generation inhibitor, is a TKI of ALK and Receptor Tyrosine Kinase C-Ros Oncogene I (ROS-1). It is also a potent TKI that is effectively against known resistant mutants that mediate resistance to first- and second-generation ALK-TKIs. Despite the efficacy and safety data derived from the pivotal phase I/II clinical trial, there are limited data describing the use of lorlatinib and its outcomes in real-world practice settings outside the highly controlled environs of clinical trials. The objective of this study is therefore to evaluate real-world systemic treatment patterns, clinical outcome, therapeutic effect, safety profile of Lorlatinib in advanced NSCLC patients, and also factors associated with clinical outcome in those Lorlatinib treated patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lorlatinib | Patients received lorlatinib treatment under EAP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorlatinib | Drug | ALK/ROS1 tyrosine kinase inhibitor |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants According to First Line Therapy Treatment Pattern From Initial Diagnosis to Current Lorlatinib Treatment | Number of participants according to first line therapy treatment pattern was reported in this outcome measure. | Baseline; data retrieved from medical records and observed in this study for approximately 5 months and 28 days |
| Objective Response Rate (ORR) During Lorlatinib Treatment | ORR was defined as the percentage of participants in whom complete response (CR), or partial response (PR) was observed. According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: 1) CR is defined as disappearance of all target lesions or partial response (PR) defined as >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD . | From first dose of lorlatinib until 30 Sep 2020 or death whichever occurred first (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days |
| Overall Survival | Overall survival was defined as the time from the date of first dose of lorlatinib to the date of death, censored at the participant's last contact date or the data cutoff date, whichever was earlier. Overall survival was evaluated using Kaplan-Meier method. | From first dose of lorlatinib until date of death or censoring date (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days |
| Progression Free Survival (PFS) For Lorlatinib Treatment | PFS refers to the duration from the first study treatment of Lorlatinib to the first documentation of disease progression or death or censored date. According to RECIST, progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progression. PFS was evaluated using the Kaplan-Meier method. |
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Inclusion Criteria:
Exclusion Criteria:
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All subjects will be enrolled from Lorlatinib Compassionate Use Program (CUP) and should be entered into this observational study at the physician's discretion.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHANG GUNG MEMORIAL HOSPITAL Kaohsiung Branch | Kaohsiung City | 83301 | Taiwan | |||
| Chung Shan Medical University Hospital |
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| 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 who were treated with Lorlatinib for advanced non-small cell lung cancer (NSCLC), progressed on first- or second- generation tyrosine kinase inhibitor (TKI) and who had participated in Lorlatinib compassionate use program (CUP) were observed in this study at the physician's discretion.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lorlatinib | Participants (among Taiwanese population) diagnosed with NSCLC who progressed on first- or second- generation TKI chemotherapy and were treated with lorlatinib under real world clinical settings as per physician judgement, were observed in this study. Data was collected from medical records. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Analysis population included all eligible participants whose data were observed in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Lorlatinib | Participants (among Taiwanese population) diagnosed with NSCLC who progressed on first- or second- generation TKI chemotherapy and were treated with lorlatinib under real world clinical settings as per physician judgement, were observed in this study. Data was collected from medical records. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants According to First Line Therapy Treatment Pattern From Initial Diagnosis to Current Lorlatinib Treatment | Number of participants according to first line therapy treatment pattern was reported in this outcome measure. | Analysis population included all eligible participants whose data were observed in the study. | Posted | Count of Participants | Participants | Baseline; data retrieved from medical records and observed in this study for approximately 5 months and 28 days |
|
From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days
Safety analysis set included participants who received at least one dose of Lorlatinib.
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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 | Lorlatinib | Participants (among Taiwanese population) diagnosed with NSCLC who progressed on first- or second- generation TKI chemotherapy and were treated with lorlatinib under real world clinical settings as per physician judgement, were observed in this study. Data was collected from medical records. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA24.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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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 | Dec 11, 2019 | Feb 17, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 23, 2020 | Feb 17, 2026 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000590786 | lorlatinib |
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| From first dose of lorlatinib until date of death or censoring date (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days |
| 1-year OS Rate on Lorlatinib | OS was defined as the time from the date of first dose of lorlatinib to the date of death, censored at the participant's last contact date or the data cutoff date, whichever was earlier. In this outcome measure percentage of participants who survived for 1 year are reported. | 1 year; data retrieved from medical records and observed in this study for approximately 5 months and 28 days |
| Time to Treatment Failure (TTF) for All NSCLC Treatment | TTF was defined as duration of first dose of any NSCLC treatment to treatment failure (defined as any discontinuation, including cancer progression, adverse events, or death). | From date of first dose of NSCLC treatment until treatment failure (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days |
| TTF for Lorlatinib Treatment Failure | TTF was defined as duration of first dose of lorlatinib treatment to treatment failure (any discontinuation, including cancer progression, adverse events, or death). | From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days |
| Number of Participants With Common Adverse Drug Reaction (ADRs) | An ADR is defined as all noxious and unintended responses to a medicinal product related to any dose. Common ADRs were hyperlipidemia, hyperglycemia, rash & itch, mental disorder, edema, body weight gain, transaminase level escalation, peripheral neuropathy, thrombocytopenia, gastrointestinal disorder, creatine kinase increased, dizziness and pneumonitis. Lorlatinib related ADR was recorded from first dose of Lorlatinib until end of study. | From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days |
| Duration of Common ADRs | An ADR is defined as all noxious and unintended responses to a medicinal product related to any dose. Common ADRs were hyperlipidemia, hyperglycemia, rash & itch, mental disorder, edema, body weight gain, transaminase level escalation, peripheral neuropathy and others (thrombocytopenia, gastrointestinal disorder, creatine kinase increased, dizziness, pneumonitis). Lorlatinib related ADR was recorded from first dose of Lorlatinib until end of study. Duration of common ADR is reported in this outcome measure. | From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days |
| Number of Participants According to Severity of Common ADRs | An ADR is defined as all noxious and unintended responses to a medicinal product related to any dose. Number of participants with Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening) and Unknown were presented in this outcome measure. Severity grades were assessed upon investigator's discretion, wherein grade 1 was minimum severity and grade 4 was maximum severity. | From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days |
| Number of Participants According to Type of Outcome of Common ADRs | An ADR is defined as all noxious and unintended responses to a medicinal product related to any dose. Participants were categorized as per their ADRs outcome as: recovered, recovered with sequelae (Sequelae refer to any complication or condition that results from a pre-existing illness, injury, or medical intervention), recovering, not recovered, and unknown. | From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days |
| Taichung |
| 402 |
| Taiwan |
| Taichung Veterans General Hospital | Taichung | 407219 | Taiwan |
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
| Taipei Veterans General Hospital | Taipei | 11217 | Taiwan |
| Chang Gung Memorial Hospital - Linkou Branch | Taoyuan City | 333 | Taiwan |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Objective Response Rate (ORR) During Lorlatinib Treatment | ORR was defined as the percentage of participants in whom complete response (CR), or partial response (PR) was observed. According to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: 1) CR is defined as disappearance of all target lesions or partial response (PR) defined as >=30 percent (%) decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD . | Evaluable response analysis set included treated participants who had tumor baseline values and at least one post-baseline tumor assessment and received at least one-month Lorlatinib treatment. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. Participants who could not be evaluated did not contribute to data reported below. | Posted | Number | Percentage of participants | From first dose of lorlatinib until 30 Sep 2020 or death whichever occurred first (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days |
|
|
|
| Primary | Overall Survival | Overall survival was defined as the time from the date of first dose of lorlatinib to the date of death, censored at the participant's last contact date or the data cutoff date, whichever was earlier. Overall survival was evaluated using Kaplan-Meier method. | Evaluable response analysis set included treated participants who had tumor baseline values and at least one post-baseline tumor assessment and received at least one-month Lorlatinib treatment. | Posted | Median | Full Range | Months | From first dose of lorlatinib until date of death or censoring date (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days |
|
|
|
| Primary | Progression Free Survival (PFS) For Lorlatinib Treatment | PFS refers to the duration from the first study treatment of Lorlatinib to the first documentation of disease progression or death or censored date. According to RECIST, progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progression. PFS was evaluated using the Kaplan-Meier method. | Evaluable response analysis set included participants who had tumor baseline values and at least one post-baseline tumor assessment and received at least one-month Lorlatinib treatment. | Posted | Median | Full Range | Months | From first dose of lorlatinib until date of death or censoring date (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days |
|
|
|
| Primary | 1-year OS Rate on Lorlatinib | OS was defined as the time from the date of first dose of lorlatinib to the date of death, censored at the participant's last contact date or the data cutoff date, whichever was earlier. In this outcome measure percentage of participants who survived for 1 year are reported. | Evaluable response analysis set included treated participants who had tumor baseline values and at least one post-baseline tumor assessment and received at least one-month Lorlatinib treatment. | Posted | Number | Percentage of participants | 1 year; data retrieved from medical records and observed in this study for approximately 5 months and 28 days |
|
|
|
| Primary | Time to Treatment Failure (TTF) for All NSCLC Treatment | TTF was defined as duration of first dose of any NSCLC treatment to treatment failure (defined as any discontinuation, including cancer progression, adverse events, or death). | Evaluable response analysis set included treated participants who had tumor baseline values and at least one post-baseline tumor assessment and received at least one-month Lorlatinib treatment. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Median | Full Range | Months | From date of first dose of NSCLC treatment until treatment failure (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days |
|
|
|
| Primary | TTF for Lorlatinib Treatment Failure | TTF was defined as duration of first dose of lorlatinib treatment to treatment failure (any discontinuation, including cancer progression, adverse events, or death). | Evaluable response analysis set included participants who had tumor baseline values and at least one post-baseline tumor assessment and received at least one-month Lorlatinib treatment. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. | Posted | Median | Full Range | Months | From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days |
|
|
|
| Primary | Number of Participants With Common Adverse Drug Reaction (ADRs) | An ADR is defined as all noxious and unintended responses to a medicinal product related to any dose. Common ADRs were hyperlipidemia, hyperglycemia, rash & itch, mental disorder, edema, body weight gain, transaminase level escalation, peripheral neuropathy, thrombocytopenia, gastrointestinal disorder, creatine kinase increased, dizziness and pneumonitis. Lorlatinib related ADR was recorded from first dose of Lorlatinib until end of study. | Safety analysis set included participants who received at least one dose of Lorlatinib. | Posted | Count of Participants | Participants | From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days |
|
|
|
| Primary | Duration of Common ADRs | An ADR is defined as all noxious and unintended responses to a medicinal product related to any dose. Common ADRs were hyperlipidemia, hyperglycemia, rash & itch, mental disorder, edema, body weight gain, transaminase level escalation, peripheral neuropathy and others (thrombocytopenia, gastrointestinal disorder, creatine kinase increased, dizziness, pneumonitis). Lorlatinib related ADR was recorded from first dose of Lorlatinib until end of study. Duration of common ADR is reported in this outcome measure. | Safety analysis set included participants who received at least one dose of Lorlatinib. Here, all participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not be evaluable for each row. "Number analyzed" signifies the number of participants with the specified ADR. | Posted | Mean | Standard Deviation | Months | From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days |
|
|
|
| Primary | Number of Participants According to Severity of Common ADRs | An ADR is defined as all noxious and unintended responses to a medicinal product related to any dose. Number of participants with Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (life-threatening) and Unknown were presented in this outcome measure. Severity grades were assessed upon investigator's discretion, wherein grade 1 was minimum severity and grade 4 was maximum severity. | Safety analysis set included participants who received at least one dose of Lorlatinib. Here, all participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not be evaluable for each row. "Number analyzed" signifies the number of participants with the specified ADR. | Posted | Count of Participants | Participants | From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days |
|
|
|
| Primary | Number of Participants According to Type of Outcome of Common ADRs | An ADR is defined as all noxious and unintended responses to a medicinal product related to any dose. Participants were categorized as per their ADRs outcome as: recovered, recovered with sequelae (Sequelae refer to any complication or condition that results from a pre-existing illness, injury, or medical intervention), recovering, not recovered, and unknown. | Safety analysis set included participants who received at least one dose of Lorlatinib. Here, all participants reported under "Overall Number of Participants Analyzed" contributed data to the table; however, may not be evaluable for each row. "Number analyzed" signifies the number of participants with the specified ADR. | Posted | Count of Participants | Participants | From date of first dose of lorlatinib until end of study (maximum up to 41.1 months); data retrieved from medical records and observed in this study for approximately 5 months and 28 days |
|
|
|
| 0 |
| 73 |
| 0 |
| 73 |
| 41 |
| 73 |
| Hypereosinophilia | Blood and lymphatic system disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Lymph node pain | Blood and lymphatic system disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Neutrophilia | Blood and lymphatic system disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Congestive heart failure | Cardiac disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Tricuspid insufficiency | Cardiac disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Disorder thyroid | Endocrine disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Abdominal bloating | Gastrointestinal disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Bloody stool | Gastrointestinal disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Mucositis oral | Gastrointestinal disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Ulcer intestinal | Gastrointestinal disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Fever | General disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Mucositis | General disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Axillary pain | General disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Allergic reaction | Immune system disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Abscess | Infections and infestations | MedDRA24.1 | Non-systematic Assessment |
|
| Abscess oral | Infections and infestations | MedDRA24.1 | Non-systematic Assessment |
|
| Acute gastroenteritis | Infections and infestations | MedDRA24.1 | Non-systematic Assessment |
|
| Acute laryngopharyngitis | Infections and infestations | MedDRA24.1 | Non-systematic Assessment |
|
| Acute nasopharyngitis | Infections and infestations | MedDRA24.1 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA24.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA24.1 | Non-systematic Assessment |
|
| Chronic periodontitis | Infections and infestations | MedDRA24.1 | Non-systematic Assessment |
|
| Flu | Infections and infestations | MedDRA24.1 | Non-systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA24.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA24.1 | Non-systematic Assessment |
|
| Cellulitis of arm | Infections and infestations | MedDRA24.1 | Non-systematic Assessment |
|
| Periodontosis | Infections and infestations | MedDRA24.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA24.1 | Non-systematic Assessment |
|
| Septic shock | Infections and infestations | MedDRA24.1 | Non-systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA24.1 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA24.1 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA24.1 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA24.1 | Non-systematic Assessment |
|
| Dermatitis radiation | Injury, poisoning and procedural complications | MedDRA24.1 | Non-systematic Assessment |
|
| Wound pain | Injury, poisoning and procedural complications | MedDRA24.1 | Non-systematic Assessment |
|
| Activated partial thromboplastin time prolonged | Investigations | MedDRA24.1 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA24.1 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA24.1 | Non-systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA24.1 | Non-systematic Assessment |
|
| Creatinine increased | Investigations | MedDRA24.1 | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA24.1 | Non-systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA24.1 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA24.1 | Non-systematic Assessment |
|
| Weight loss | Investigations | MedDRA24.1 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Muscle soreness | Musculoskeletal and connective tissue disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Cramp | Musculoskeletal and connective tissue disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Medication-related osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Temporomandibular joint disorder | Musculoskeletal and connective tissue disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Tendon pain | Musculoskeletal and connective tissue disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Numbness of lower extremities | Nervous system disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Hemorrhagic cystitis | Renal and urinary disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Hydronephrosis | Renal and urinary disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Runny nose | Respiratory, thoracic and mediastinal disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Sore throat | Respiratory, thoracic and mediastinal disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Sputum discolored | Respiratory, thoracic and mediastinal disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Bed sore | Skin and subcutaneous tissue disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Dyshidrosis | Skin and subcutaneous tissue disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Hand and foot syndrome | Skin and subcutaneous tissue disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Itchy skin | Skin and subcutaneous tissue disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Chronic skin ulcer | Skin and subcutaneous tissue disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Seborrhea capitis | Skin and subcutaneous tissue disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Skin eruption | Skin and subcutaneous tissue disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Skin rash | Skin and subcutaneous tissue disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Itchy rash | Skin and subcutaneous tissue disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Raynaud's phenomenon | Vascular disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Hot flashes | Vascular disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA24.1 | Non-systematic Assessment |
|
| Cellulitis of mouth | Infections and infestations | MedDRA24.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications 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.
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Title | Measurements |
|---|---|
|
| Mental disorder |
|
| Edema |
|
| Body weight gain |
|
| Transaminase level escalation |
|
| Peripheral Neuropathy |
|
| Thrombocytopenia |
|
| Gastrointestinal disorder |
|
| Creatine kinase increased |
|
| Dizziness |
|
| Pneumonitis |
|
|
| Rash & itch |
|
|
| Mental disorder |
|
|
| Edema |
|
|
| Body weight gain |
|
|
| Transaminase level escalation |
|
|
| Peripheral Neuropathy |
|
|
| Others |
|
|
|
| Hyperlipidemia (Grade 3) |
|
|
| Hyperlipidemia (Grade 4) |
|
|
| Hyperlipidemia (Grade Unknown) |
|
|
| Hyperglycemia (Grade 1) |
|
|
| Hyperglycemia (Grade 2) |
|
|
| Hyperglycemia (Grade 3) |
|
|
| Hyperglycemia (Grade 4) |
|
|
| Hyperglycemia (Grade Unknown) |
|
|
| Rash & itch (Grade 1) |
|
|
| Rash & itch (Grade 2) |
|
|
| Rash & itch (Grade 3) |
|
|
| Rash & itch (Grade 4) |
|
|
| Rash & itch (Grade Unknown) |
|
|
| Mental disorder (Grade 1) |
|
|
| Mental disorder (Grade 2) |
|
|
| Mental disorder (Grade 3) |
|
|
| Mental disorder (Grade 4) |
|
|
| Mental disorder (Grade Unknown) |
|
|
| Edema (Grade 1) |
|
|
| Edema (Grade 2) |
|
|
| Edema (Grade 3) |
|
|
| Edema (Grade 4) |
|
|
| Edema (Grade Unknown) |
|
|
| Body weight gain (Grade 1) |
|
|
| Body weight gain (Grade 2) |
|
|
| Body weight gain (Grade 3) |
|
|
| Body weight gain (Grade 4) |
|
|
| Body weight gain (Grade Unknown) |
|
|
| Transaminase level escalation (Grade 1) |
|
|
| Transaminase level escalation (Grade 2) |
|
|
| Transaminase level escalation (Grade 3) |
|
|
| Transaminase level escalation (Grade 4) |
|
|
| Transaminase level escalation (Grade Unknown) |
|
|
| Peripheral Neuropathy (Grade 1) |
|
|
| Peripheral Neuropathy (Grade 2) |
|
|
| Peripheral Neuropathy (Grade 3) |
|
|
| Peripheral Neuropathy (Grade 4) |
|
|
| Peripheral Neuropathy (Grade Unknown) |
|
|
| Others (Grade 1) |
|
|
| Others (Grade 2) |
|
|
| Others (Grade 3) |
|
|
| Others (Grade 4) |
|
|
| Others (Grade Unknown) |
|
|
|
| Hyperlipidemia (Recovering) |
|
|
| Hyperlipidemia (Not Recovered) |
|
|
| Hyperlipidemia (Unknown) |
|
|
| Hyperglycemia (Recovered) |
|
|
| Hyperglycemia (Recovered with Sequelae) |
|
|
| Hyperglycemia (Recovering) |
|
|
| Hyperglycemia (Not Recovered) |
|
|
| Hyperglycemia (Unknown) |
|
|
| Rash & Itch (Recovered) |
|
|
| Rash & Itch (Recovered with Sequelae) |
|
|
| Rash & Itch (Recovering) |
|
|
| Rash & Itch (Not Recovered) |
|
|
| Rash & Itch (Unknown) |
|
|
| Mental disorder (Recovered) |
|
|
| Mental disorder (Recovered with Sequelae) |
|
|
| Mental disorder (Recovering) |
|
|
| Mental disorder (Not Recovered) |
|
|
| Mental disorder (Unknown) |
|
|
| Edema (Recovered) |
|
|
| Edema (Recovered with Sequelae) |
|
|
| Edema (Recovering) |
|
|
| Edema (Not Recovered) |
|
|
| Edema (Unknown) |
|
|
| Body weight gain (Recovered) |
|
|
| Body weight gain (Recovered with Sequelae) |
|
|
| Body weight gain (Recovering) |
|
|
| Body weight gain (Not Recovered) |
|
|
| Body weight gain (Unknown) |
|
|
| Transaminase level escalation (Recovered) |
|
|
| Transaminase level escalation (Recovered with Sequelae) |
|
|
| Transaminase level escalation (Recovering) |
|
|
| Transaminase level escalation (Not Recovered) |
|
|
| Transaminase level escalation (Unknown) |
|
|
| Peripheral Neuropathy (Recovered) |
|
|
| Peripheral Neuropathy (Recovered with Sequelae) |
|
|
| Peripheral Neuropathy (Recovering) |
|
|
| Peripheral Neuropathy (Not Recovered) |
|
|
| Peripheral Neuropathy (Unknown) |
|
|
| Others (Recovered) |
|
|
| Others (Recovered with Sequelae) |
|
|
| Others (Recovering) |
|
|
| Others (Not Recovered) |
|
|
| Others (Unknown) |
|
|