Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| ADP-0011-004 | Other Identifier | Adaptimmune Therapeutics | |
| 2016-002517-21 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial will evaluate safety and efficacy of letetresgene autoleucel (GSK3377794) in participants with metastatic NSCLC.
New York esophageal antigen-1 (NY-ESO-1) and L antigen family member (LAGE)-1a antigens are tumor-associated proteins that have been found in several tumor types. Clinical trials using adoptively transferred T-cells directed against NY-ESO-1/LAGE-1a have shown objective responses. Letetresgene autoleucel (GSK3377794) is the first generation of NY-ESO-1 specific T-cell receptor engineered TCR T-cells. This protocol investigates letetresgene autoleucel treatment in Human Leukocyte Antigen (HLA)*-A*02+ participants with NY-ESO1+ advanced metastatic non-small cell lung cancer as second line treatment.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| letetresgene autoleucel (GSK3377794) | Experimental | Eligible participants will be leukapheresed to manufacture engineered T-cells. Participants will then receive letetresgene autoleucel (GSK3377794), as a single intravenous (IV) infusion after completing lymphodepleting chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| letetresgene autoleucel (GSK3377794) | Drug | letetresgene autoleucel (GSK3377794) as an IV infusion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or is clinically significant or requires intervention to prevent one of the outcomes listed before. Number of participants with common (greater than or equal to [>=]5 percent[%]) non-serious AEs and SAEs are presented. | Up to 24 months |
| Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline | Blood samples were collected for the analysis of following hematology parameters: hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. Laboratory parameters were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.03 where, Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline is the most recent, non-missing value from a central laboratory within 7 days prior to the lymphodepleting chemotherapy. An increase in grade is defined as an increase in CTCAE grade relative to Baseline grade. Data for any grade increase at worst-case post-Baseline is presented | Up to 24 months |
| Number of Participants With Any Grade Increase in Clinical Chemistry Parameters | Blood samples were collected for analysis of clinical chemistry parameters: glucose (Gl), albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin (Bil), creatinine (Creat), potassium (Pot), magnesium (Mg), phosphate (Ph), sodium (Sod) and calcium. Laboratory parameters were graded according to NCI-CTCAE version 4.03 where, Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. An increase in grade is defined as an increase in CTCAE grade relative to Baseline grade. Data for any grade increase at worst-case post-Baseline is presented. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | ORR is defined as the percentage of participants with a confirmed Partial response (PR) or Complete response (CR) as the Best overall response (BOR), as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. Confidence Interval (CI) was calculated using the exact method. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the Baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Miami | Florida | 33136 | United States | ||
| GSK Investigational Site |
IPD for this study will be made available via the Clinical Study Data Request site.
IPD will be made available within 6 months of publishing the results of the primary endpoints, key secondary endpoints and safety data of the study.
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Participants were screened for the specified HLA alleles and target antigen expression (NY-ESO-1), and evaluated for study eligibility. A total of 10 participants who met all the eligibility criteria were enrolled in this study which consisted of Intent-to-Treat (ITT) population. This study was conducted across 3 sites in the United States.
This was an open-label study evaluating the safety and tolerability of autologous T-Cells expressing enhanced T-cell receptors (TCRs) specific for New York esophageal squamous cell carcinoma (NY-ESO)-1 (letetresgene autoleucel, lete-cel, GSK3377794) in Human Leukocyte Antigen (HLA)-A*02:01, HLA-A*02:05 and/or HLA-A*02:06 participants with stage IIIb or stage IV non-small cell lung cancer (NSCLC).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Lete-cel | Eligible participants were leukapheresed to manufacture lete-cel. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single intravenous (IV) infusion of lete-cel. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Lete-cel | Eligible participants were leukapheresed to manufacture lete-cel. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single intravenous (IV) infusion of lete-cel. |
| 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 With Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or is clinically significant or requires intervention to prevent one of the outcomes listed before. Number of participants with common (greater than or equal to [>=]5 percent[%]) non-serious AEs and SAEs are presented. | ITT population consisted of all participants who were enrolled in the trial and met all eligibility criteria. | Posted | Count of Participants | Participants | Up to 24 months |
|
All-cause mortality, SAEs and common (>=5%) non-serious AEs were collected from the enrollment to 24 months
All-cause mortality, SAEs and common non-serious AEs were reported for the ITT Population which comprised of all participants enrolled in the study.
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 | Lete-cel | Eligible participants were leukapheresed to manufacture lete-cel. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single intravenous (IV) infusion of lete-cel. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cytokine release syndrome | Immune system disorders | MedDRA 23.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphocyte count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 25, 2019 | Jul 9, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 2, 2020 | Jul 15, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cyclophosphamide | Drug | Cyclophosphamide will be used as a lymphodepleting chemotherapy. |
|
| Fludarabine | Drug | Fludarabine will be used as a lymphodepleting chemotherapy. |
|
| Up to 24 months |
| Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | 12-lead ECGs were recorded in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate and measured PR, RR, QRS and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Data for number of participants with abnormal not clinically significant (NCS) and clinically significant (CS) ECG findings for worst case post-Baseline have been presented. Clinically significant abnormal laboratory findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | Up to 24 months |
| Change From Baseline in Oxygen Saturation | Oxygen saturation measures the capacity of blood to transport oxygen to other parts of the body. Oxygen saturation was measured using a pulse oximeter. Baseline is the most recent, non-missing value within 7 days prior to initiating the lymphodepleting chemotherapy. Change from Baseline is the post-Baseline visit value minus Baseline value. | Baseline, Day 1 (pre-dose, 5, 15, and 30 minutes, 1, 1.5, 2, and 4 hours post dose), Days 2, 3, 4, 5, 8 and Week 2 |
| Up to 24 Months |
| Time to Response | Time to response is defined as the interval of time (in months) between the date of T-cell infusion and the first documented evidence of response (PR or CR) in the subset of participants with a confirmed PR or CR as the BOR as assessed by the investigator per RECIST v1.1. | Up to 24 months |
| Duration of Response | Duration of response (DoR), defined as the interval of time in months from first documented evidence of PR or better to the time when disease progression is documented as assessed by RECIST v1.1 or death due to any cause among participants with a confirmed PR or CR as the BOR. | Up to 24 months |
| Disease Control Rate (DCR) | DCR is defined as the percentage of participants with a stable disease (SD) or better as the BOR (Confirmed PR, confirmed CR, or SD >=12 weeks), as assessed by the investigator per RECIST v1.1. CI was calculated using the exact method. | Up to 24 months |
| Progression-Free Survival (PFS) by Investigator Assessment | Progression-free survival (PFS) is defined as the interval of time (in months) between the date of T-cell infusion and the earlier of the date of disease progression as assessed by the investigator and the date of death due to any cause. Progressive Disease (PD) 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. PFS based on responses assessed by investigator per RECIST v1.1 is presented. Median and inter-quartile range (first quartile and third quartile) are presented. | Up to 24 months |
| Tampa |
| Florida |
| 33612 |
| United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| Death prior to T-cell infusion |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
Eligible participants were leukapheresed to manufacture lete-cel. Participants then underwent lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by a single intravenous (IV) infusion of lete-cel. |
|
|
| Primary | Number of Participants With Hematology Results by Maximum Grade Increase Post-Baseline | Blood samples were collected for the analysis of following hematology parameters: hemoglobin, lymphocytes, neutrophils, platelets and leukocytes. Laboratory parameters were graded according to National Cancer Institute-Common Toxicity Criteria for Adverse Events (NCI-CTCAE) version 4.03 where, Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Baseline is the most recent, non-missing value from a central laboratory within 7 days prior to the lymphodepleting chemotherapy. An increase in grade is defined as an increase in CTCAE grade relative to Baseline grade. Data for any grade increase at worst-case post-Baseline is presented | Modified (m)ITT population consisted of all participants in the ITT population who received NYESO-1 T cell infusion. | Posted | Count of Participants | Participants | Up to 24 months |
|
|
|
| Primary | Number of Participants With Any Grade Increase in Clinical Chemistry Parameters | Blood samples were collected for analysis of clinical chemistry parameters: glucose (Gl), albumin, alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin (Bil), creatinine (Creat), potassium (Pot), magnesium (Mg), phosphate (Ph), sodium (Sod) and calcium. Laboratory parameters were graded according to NCI-CTCAE version 4.03 where, Grade1: mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. An increase in grade is defined as an increase in CTCAE grade relative to Baseline grade. Data for any grade increase at worst-case post-Baseline is presented. | mITT Population | Posted | Count of Participants | Participants | Up to 24 months |
|
|
|
| Primary | Number of Participants With Worst Case Post-Baseline Abnormal Electrocardiogram (ECG) Findings | 12-lead ECGs were recorded in semi-supine position after 5 minutes rest using an ECG machine that automatically calculated the heart rate and measured PR, RR, QRS and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Data for number of participants with abnormal not clinically significant (NCS) and clinically significant (CS) ECG findings for worst case post-Baseline have been presented. Clinically significant abnormal laboratory findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. | mITT Population | Posted | Count of Participants | Participants | Up to 24 months |
|
|
|
| Primary | Change From Baseline in Oxygen Saturation | Oxygen saturation measures the capacity of blood to transport oxygen to other parts of the body. Oxygen saturation was measured using a pulse oximeter. Baseline is the most recent, non-missing value within 7 days prior to initiating the lymphodepleting chemotherapy. Change from Baseline is the post-Baseline visit value minus Baseline value. | mITT Population. Only those participants with data available at the specified data points were analyzed (represented by n=X in category titles). | Posted | Median | Full Range | Percentage of oxygen | Baseline, Day 1 (pre-dose, 5, 15, and 30 minutes, 1, 1.5, 2, and 4 hours post dose), Days 2, 3, 4, 5, 8 and Week 2 |
|
|
|
| Secondary | Overall Response Rate (ORR) | ORR is defined as the percentage of participants with a confirmed Partial response (PR) or Complete response (CR) as the Best overall response (BOR), as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. Confidence Interval (CI) was calculated using the exact method. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the Baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<)10 millimeters. | mITT Population | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 24 Months |
|
|
|
| Secondary | Time to Response | Time to response is defined as the interval of time (in months) between the date of T-cell infusion and the first documented evidence of response (PR or CR) in the subset of participants with a confirmed PR or CR as the BOR as assessed by the investigator per RECIST v1.1. | mITT Population. Only those participants with data available at the specified data points were analyzed. | Posted | Number | Months | Up to 24 months |
|
|
|
| Secondary | Duration of Response | Duration of response (DoR), defined as the interval of time in months from first documented evidence of PR or better to the time when disease progression is documented as assessed by RECIST v1.1 or death due to any cause among participants with a confirmed PR or CR as the BOR. | mITT Population. Only those participants with data available at the specified data points were analyzed. | Posted | Number | Months | Up to 24 months |
|
|
|
| Secondary | Disease Control Rate (DCR) | DCR is defined as the percentage of participants with a stable disease (SD) or better as the BOR (Confirmed PR, confirmed CR, or SD >=12 weeks), as assessed by the investigator per RECIST v1.1. CI was calculated using the exact method. | mITT Population | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 24 months |
|
|
|
| Secondary | Progression-Free Survival (PFS) by Investigator Assessment | Progression-free survival (PFS) is defined as the interval of time (in months) between the date of T-cell infusion and the earlier of the date of disease progression as assessed by the investigator and the date of death due to any cause. Progressive Disease (PD) 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. PFS based on responses assessed by investigator per RECIST v1.1 is presented. Median and inter-quartile range (first quartile and third quartile) are presented. | mITT Population | Posted | Median | Inter-Quartile Range | Months | Up to 24 months |
|
|
|
| 4 |
| 10 |
| 4 |
| 10 |
| 6 |
| 10 |
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Encephalopathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Haemorrhage intracranial | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 23.0 | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Lymph node pain | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 23.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Paralysis | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Spinal cord compression | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Ventricular tachycardia | Cardiac disorders | MedDRA 23.0 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Strongyloidiasis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 23.0 | Systematic Assessment |
|
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 23.0 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Rash macular | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 23.0 | Systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA 23.0 | Systematic Assessment |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| Title | Measurements |
|---|---|
|
| Lymphocytes decreased |
|
| Neutrophils |
|
| Platelets |
|
| Leukocytes (Leukocytosis) |
|
| Leukocytes (Leukopenia) |
|
| Title | Measurements |
|---|---|
|
| ALP |
|
| ALT |
|
| AST |
|
| Bil |
|
| Creat |
|
| Pot, Hyperkalemia |
|
| Pot, Hypokalemia |
|
| Mg, Hypermagnesemia |
|
| Mg, Hypomagnesemia |
|
| Ph |
|
| Sod, Hypernatremia |
|
| Sod, Hyponatremia |
|
| Calcium, Hypercalcemia |
|
| Calcium, Hypocalcemia |
|
|
| Day 1, 15 minutes post dose, n=4 |
|
|
| Day 1, 30 minutes post dose, n=4 |
|
|
| Day 1, 1 hour post dose, n=5 |
|
|
| Day 1, 1.5 hours post dose, n=2 |
|
|
| Day 1, 2 hours post dose, n=3 |
|
|
| Day 1, 4 hours post dose, n=4 |
|
|
| Day 2, n=4 |
|
|
| Day 3, n=5 |
|
|
| Day 4 , n=5 |
|
|
| Day 5, n=5 |
|
|
| Day 8, n=4 |
|
|
| Week 2, n=4 |
|
|