Lung Cancer, Non-Small Cell
Conditions
Keywords
ASCI, Immunotherapeutic, MAGRIT, Tumor antigen, Non-small-cell lung cancer, Adjuvant cancer therapy
Brief summary
The purpose of this clinical trial is to demonstrate the benefit of the immunotherapeutic product GSK1572932A when given to patients with Non-Small Cell Lung Cancer, after removal of their tumor. A course of 13 injections will be administered over 27 months. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Interventions
BIOLOGICALGSK1572932A Antigen-Specific Cancer Immunotherapeutic
Intramuscular administration, 13 doses
BIOLOGICALPlacebo Control
Intramuscular administration, 13 doses
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patient with completely resected, pathologically proven stage IB, II or IIIA NSCLC. * Written informed consent for MAGE-A3 expression screening on tumor biopsy has been obtained from the patient prior to shipment of the sample for expression testing (before or just after surgical resection), and written informed consent for the complete study has been obtained prior to the performance of any other protocol-specific procedure. * Patient is ≥ 18 years of age at the time of signature of the first informed consent form. * The patient's tumor shows expression of MAGE-A3 gene * The surgical technique for resection of the patient's tumor is anatomical, involving at least a lobectomy or a sleeve lobectomy; * The mediastinal lymph node sampling is done according to study protocol guidelines; * The patient is free of metastasis, as confirmed by a negative baseline computer tomogram (CT scan) of the chest, upper abdomen and CT scan or MRI of the brain. Other examinations should be performed as clinically indicated. Note that if randomization is taking place within 8 weeks after surgery, brain CT scans or brain MRI performed up to 4 weeks before surgery do not have to be repeated. * ECOG performance status of 0, 1 or 2 at the time of randomization. * Adequate bone-marrow reserve, adequate renal function and adequate hepatic function as assessed by standard laboratory criteria, and defined as: Absolute neutrophil count ≥ 1.0 x 10E9/L Platelet count ≥ 75 x 10E9/L Serum creatinine ≤ 1.5 times the Upper Limit of Normal (ULN) ≤ 3.0 times the ULN if due to platinum adjuvant chemotherapy Total bilirubin ≤ 1.5 times the ULN Alanine transaminase (ALAT) ≤ 2.5 times the ULN * If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to administration of study treatment, have a negative pregnancy test and continue such precautions during all study treatment period and for 2 months after completion of the injection series. * In the view of the investigator, the patient can and will comply with the requirements of the protocol.
Exclusion criteria
* The primary tumor was removed by segmentectomy or wedge resection. * The patient shows any evidence of residual tumor after surgery. * The patient has received any anti-cancer specific treatment, including radiotherapy, immunotherapy, chemotherapy or neo-adjuvant chemotherapy, except: For the treatment of previous malignancies as allowed by the protocol (i.e., non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years), Administration of adjuvant platinum-based chemotherapy for the treatment of the current NSCLC is allowed between surgery and randomization. * The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and highly likely to have been cured. * History of allergic disease or reactions likely to be exacerbated by any component of the study investigational product. * The patient has an autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded. * The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents. Note: The use of prednisone, or equivalent, \<0.5 mg/kg/day (absolute maximum 40 mg/day), or inhaled corticosteroids for COPD or topical steroids is permitted. * The patient has received a major organ allograft. * The patient is known to be HIV-positive. * The patient has an uncontrolled bleeding disorder. * The patient has uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia at the time of enrolment. * The patient needs home oxygenation. * The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the trial procedures. * The patient has other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk. * The patient has received any investigational or non-registered medicinal product other than the study medication within the 30 days preceding the first dose of study medication, or plans to receive such a drug during the study period. * For female patients: the patient is pregnant or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the Overall Population | From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence \[any tumor arising in contralateral lung or outside hemithorax\]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. PYAR= n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method. |
| Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the No-CT Population | From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence \[any tumor arising in contralateral lung or outside hemithorax\]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. PYAR= n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Person Year Rate (PYAR) as Regards Overall-survival (OS) in the Overall Population | From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | OS was defined as the time interval from randomization to the date of death, irrespective of the cause of death. Patients still alive were censored at the last visit they were known to be alive. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method. |
| Person Year Rate (PYAR) as Regards Overall-survival (OS) in the No-CT Population | From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | OS was defined as the time interval from randomization to the date of death, irrespective of the cause of death. Patients still alive were censored at the last visit they were known to be alive. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method. |
| Person Year Rate (PYAR) as Regards Overall-survival (OS) in the CT Population | From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | OS was defined as the time interval from randomization to the date of death, irrespective of the cause of death. Patients still alive were censored at the last visit they were known to be alive. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method. |
| Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the Overall Population | From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | LCSS was defined as the time interval from randomization to the date of death due to lung cancer. Deaths due to other or unknown causes were censored at the date of death. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method. |
| Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the No-CT Population | From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | LCSS was defined as the time interval from randomization to the date of death due to lung cancer. Deaths due to other or unknown causes were censored at the date of death. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method. |
| Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the CT Population | From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | LCSS was defined as the time interval from randomization to the date of death due to lung cancer. Deaths due to other or unknown causes were censored at the date of death. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method. |
| Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the Overall Population | KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment. Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence \[any tumor arising in contralateral lung or outside hemithorax\]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. Median DFS KMEs in % were obtained non-parametrically by Kaplan-Meier method and confidence intervals (CIs) calculated using the Greenwood formula for standard error computation. |
| Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the CT Population | Period of follow-up was from administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | DFSS was defined as the interval from randomization to the date of disease recurrence or death due to lung cancer. Patients who had died due to another cause than lung cancer were censored on their date of death and patients alive at the time of analysis were censored on the date of last assessment. Patients with no assessment post-randomization were censored on the date of randomization. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method. |
| Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the No-CT Population | KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence \[any tumor arising in contralateral lung or outside hemithorax\]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. Median DFS KMEs in % were obtained non-parametrically by Kaplan-Meier method and confidence intervals (CIs) calculated using the Greenwood formula for standard error computation. |
| Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the CT Population | KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment. Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence \[any tumor arising in contralateral lung or outside hemithorax\]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. Median DFS KMEs in % were obtained non-parametrically by Kaplan-Meier method and confidence intervals (CIs) calculated using the Greenwood formula for standard error computation. |
| Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the Overall Population | From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | DFSS was defined as the interval from randomization to the date of disease recurrence or death due to lung cancer. Patients who had died due to another cause than lung cancer were censored on their date of death and patients alive at the time of analysis were censored on the date of last assessment. Patients with no assessment post-randomization were censored on the date of randomization. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method. |
| Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the No-CT Population | From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | DFSS was defined as the interval from randomization to the date of disease recurrence or death due to lung cancer. Patients who had died due to another cause than lung cancer were censored on their date of death and patients alive at the time of analysis were censored on the date of last assessment. Patients with no assessment post-randomization were censored on the date of randomization. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method. |
| Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR) | At Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120) | A seropositive/seronegative subject for anti-MAGE-A3 antibodies was a subject with anti-MAGE-A3 antibodies \>=/\< the seropositivity cut-off of 27 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL). A humoral responder as regards anti-MAGE-A3 antibodies was defined as 1) for initially seronegative patients, a patient with post-administration Anti-MAGE-A3 antibody concentration \>= 27 EL.U/mL; 2) for initially seropositive patients: post-treatment administration antibody concentration \>= 2 fold the pre-treatment antibody concentration. |
| Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+) | Pre-treatment (PRE), at Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120) | A seropositive subject for anti-PD antibodies was a subject with anti-PD antibodies \>= the seropositivity cut-off of 100 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL). |
| Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+) | Pre-treatment (PRE), at Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (At 12M post W120) | A seropositive subject for anti-MAGE-A3 antibodies was a subject with anti-MAGE-A3 antibodies \>= the seropositivity cut-off of 27 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL). |
| Health-related Quality of Life (HQL) Scores | At Week (W) 0 on day of treatment (DoT) (W0 DoT), W0 on day post treatment (DpT) (W0 DpT), W6 DoT, W6 DpT, W12 DoT, W12 DpT, Month (M) 6, M9, M12, M24, 6M post W120, at recurrence, and at 12M post W120 | HQL was assessed using the EQ-5D generic health state classification and valuation system. The number and percentage of patients with each score within each dimension of the EQ-5D questionnaire (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) were tabulated at each assessment for each group. Each of these scores can take 3 levels: no problem (level 1), moderate problem (level 2) or extreme problem (level 3). Resulting descriptive mean and standard deviation (SD) for the EQ-5D Utility Value (EQ-5D UV) were tabulated. Valid EQ-5D data were defined as questionnaires assessed 1) on day of and before treatment administration; or 2) on day after treatment administration for W0, W6, W12; or 3)during follow-up visits or at time of recurrence. The EQ-5D total score ranges from -0.016 (worst health state) to 1.000 (best health state). |
| Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | The status of each patient as regards ALT laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK. |
| Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | The status of each patient as regards AST laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK. |
| Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | The status of each patient as regards ALKP laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK. |
| Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | The status of each patient as regards BIL laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0) and G1. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK. |
| Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | The status of each patient as regards CREA laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK. |
| Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | The status of each patient as regards HGB laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK. |
| Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | The status of each patient as regards LEU laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK. |
| Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | The status of each patient as regards LYM laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK. |
| Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | The status of each patient as regards NEU laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2, G3 and G4. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK. |
| Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | The status of each patient as regards PLA laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK. |
| Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP) | Within the 31-day follow-up period post treatment administration, up to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | An AE was any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs reported are here below tabulated irrespective of grade, as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1), G2, G3, G4 and G5. Any here below is defined as irrespective of CTC grade reported. |
| Number of Patients With Serious Adverse Events (SAEs) - Up to Data Lock Point (DLP) | From screening (SCR) up to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | A SAE is any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject, or was a Grade 4 AE according to CTC for Adverse Events, Version 3.0. Events part of natural course of lung cancer (i.e., disease progression, recurrence) were captured towards clinical efficacy assessment (CEA) and were not reported as SAEs. Death due to a progressive disease was similarly recorded towards CEA, but not as an SAE. However, if progression of lung cancer disease was greater than normally be expected, or if investigators considered that there was a causal relationship between treatment or protocol design/procedures and disease progression/ recurrence, then it was reported as SAE. Any new cancer (non-related to lung cancer) was reported as SAE. |
| Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR) | At Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120) | A seropositive/seronegative subject for anti-PD antibodies was a subject with anti-PD antibodies ≥/\< the seropositivity cut-off of 100 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL). A humoral responder as regards anti-PD antibodies was defined as 1) for initially seronegative patients, a patient with post-administration anti-PD antibody concentration ≥ 100 EL.U/mL; 2) for initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration. |
| Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the CT Population | From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) | DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence \[any tumor arising in contralateral lung or outside hemithorax\]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Netherlands, Norway, Poland, Russia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
A total of 2315 patients were screened towards participation in the study. For 3 of these subjects informed consent forms issues were reported, and thus only 2312 subjects were considered for analyses/results Out of these 2312 subjects, 2278 were enrolled in the study.
Pre-assignment details
Out of the 2278 patients initially enrolled into the study, only 2272 patients received at least one dose of study treatment (1515 received GSK1572932 and 757 received placebo).
Participants by arm
| Arm | Count |
|---|---|
| GSK1572932 Group Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks. | 1,515 |
| Placebo Group Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks. | 757 |
| Total | 2,272 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 44 | 12 |
| Overall Study | Disease Progression / Recurrence | 449 | 224 |
| Overall Study | Other | 70 | 29 |
| Overall Study | Patients remaining ongoing at Data Lock | 101 | 55 |
| Overall Study | Protocol Violation | 12 | 7 |
| Overall Study | SAE including intercurrent illness | 76 | 42 |
Baseline characteristics
| Characteristic | GSK1572932 Group | Total | Placebo Group |
|---|---|---|---|
| Age, Continuous | 63.1 Years STANDARD_DEVIATION 8.96 | 63.2 Years STANDARD_DEVIATION 9.02 | 63.4 Years STANDARD_DEVIATION 9.15 |
| Race/Ethnicity, Customized Geographic ancestry African heritage/African American | 14 Participants | 21 Participants | 7 Participants |
| Race/Ethnicity, Customized Geographic ancestry American Indian or Alaskan Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - Central/South Asian heritage | 8 Participants | 13 Participants | 5 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - East Asian heritage | 195 Participants | 307 Participants | 112 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - Japanese heritage | 138 Participants | 209 Participants | 71 Participants |
| Race/Ethnicity, Customized Geographic ancestry Asian - South East Asian heritage | 13 Participants | 23 Participants | 10 Participants |
| Race/Ethnicity, Customized Geographic ancestry Missing confirmed | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Native Hawaiian or other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry Other | 11 Participants | 12 Participants | 1 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Arabic//North African heritage | 7 Participants | 16 Participants | 9 Participants |
| Race/Ethnicity, Customized Geographic ancestry White - Caucasian/European heritage | 1129 Participants | 1668 Participants | 539 Participants |
| Sex: Female, Male Female | 370 Participants | 549 Participants | 179 Participants |
| Sex: Female, Male Male | 1145 Participants | 1723 Participants | 578 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 30 / 1,515 | 17 / 757 |
| other Total, other adverse events | 1,225 / 1,515 | 300 / 757 |
| serious Total, serious adverse events | 330 / 1,515 | 164 / 757 |
Outcome results
Primary
Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the No-CT Population
DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence \[any tumor arising in contralateral lung or outside hemithorax\]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. PYAR= n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.
Time frame: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1572932 Group | Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the No-CT Population | 0.169 events/person-years |
| Placebo Group | Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the No-CT Population | 0.178 events/person-years |
Comparison: Analysis compared DFS PYAR between groups for the period from 1st treatment dose to DLP. A Cox model was used to evaluate treatment efficacy (TE). TE was calculated as PYAR in GSK1572932 No-CT Group (PYAR1) divided by PYAR in Placebo No-CT Group (PYAR2) and weighed for adjustment factors. This comparison in all patients (overall population) also included taking into account weighing using randomization-minimization factors (RMF) as regressors.p-value: 0.757295% CI: [0.797, 1.179]Regression, Cox
Primary
Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the Overall Population
DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence \[any tumor arising in contralateral lung or outside hemithorax\]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. PYAR= n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.
Time frame: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1572932 Group | Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the Overall Population | 0.17 events/person-years |
| Placebo Group | Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the Overall Population | 0.168 events/person-years |
Comparison: Analysis compared DFS PYAR between groups for period from 1st treatment dose to DLP. A Cox model was used to evaluate treatment efficacy (TE). TE was calculated as PYAR in GSK1572932 Group (PYAR1) divided by PYAR in Placebo Group (PYAR2), and weighed for adjustment factors. This comparison in all patients (overall population) also included taking into account stratification by previous CT vs. No-CT treatment and weighing using randomization-minimization factors (RMF) as regressors.p-value: 0.737995% CI: [0.891, 1.177]Regression, Cox
Secondary
Health-related Quality of Life (HQL) Scores
HQL was assessed using the EQ-5D generic health state classification and valuation system. The number and percentage of patients with each score within each dimension of the EQ-5D questionnaire (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) were tabulated at each assessment for each group. Each of these scores can take 3 levels: no problem (level 1), moderate problem (level 2) or extreme problem (level 3). Resulting descriptive mean and standard deviation (SD) for the EQ-5D Utility Value (EQ-5D UV) were tabulated. Valid EQ-5D data were defined as questionnaires assessed 1) on day of and before treatment administration; or 2) on day after treatment administration for W0, W6, W12; or 3)during follow-up visits or at time of recurrence. The EQ-5D total score ranges from -0.016 (worst health state) to 1.000 (best health state).
Time frame: At Week (W) 0 on day of treatment (DoT) (W0 DoT), W0 on day post treatment (DpT) (W0 DpT), W6 DoT, W6 DpT, W12 DoT, W12 DpT, Month (M) 6, M9, M12, M24, 6M post W120, at recurrence, and at 12M post W120
Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| GSK1572932 Group | Health-related Quality of Life (HQL) Scores | EQ-5D UV, At W0 DoT | 0.83 Scores on a scale | Standard Deviation 0.152 |
| GSK1572932 Group | Health-related Quality of Life (HQL) Scores | EQ-5D UV, At W12 DpT | 0.841 Scores on a scale | Standard Deviation 0.152 |
| GSK1572932 Group | Health-related Quality of Life (HQL) Scores | EQ-5D UV, At 6M post W120 | 0.723 Scores on a scale | Standard Deviation 0.298 |
| GSK1572932 Group | Health-related Quality of Life (HQL) Scores | EQ-5D UV, At recurrence | 0.662 Scores on a scale | Standard Deviation 0.343 |
| GSK1572932 Group | Health-related Quality of Life (HQL) Scores | EQ-5D UV, At 12M post W120 | 0.753 Scores on a scale | Standard Deviation 0.199 |
| GSK1572932 Group | Health-related Quality of Life (HQL) Scores | EQ-5D UV, At W0 DpT | 0.788 Scores on a scale | Standard Deviation 0.182 |
| GSK1572932 Group | Health-related Quality of Life (HQL) Scores | EQ-5D UV, At W6 DoT | 0.837 Scores on a scale | Standard Deviation 0.182 |
| GSK1572932 Group | Health-related Quality of Life (HQL) Scores | EQ-5D UV, At W6 DpT | 0.798 Scores on a scale | Standard Deviation 0.205 |
| GSK1572932 Group | Health-related Quality of Life (HQL) Scores | EQ-5D UV, At W12 DoT | 0.848 Scores on a scale | Standard Deviation 0.158 |
| GSK1572932 Group | Health-related Quality of Life (HQL) Scores | EQ-5D UV, At M6 | 0.847 Scores on a scale | Standard Deviation 0.182 |
| GSK1572932 Group | Health-related Quality of Life (HQL) Scores | EQ-5D UV, At M9 | 0.84 Scores on a scale | Standard Deviation 0.197 |
| GSK1572932 Group | Health-related Quality of Life (HQL) Scores | EQ-5D UV, At M12 | 0.857 Scores on a scale | Standard Deviation 0.166 |
| GSK1572932 Group | Health-related Quality of Life (HQL) Scores | EQ-5D UV, At M24 | 0.855 Scores on a scale | Standard Deviation 0.179 |
| Placebo Group | Health-related Quality of Life (HQL) Scores | EQ-5D UV, At W12 DpT | 0.831 Scores on a scale | Standard Deviation 0.211 |
| Placebo Group | Health-related Quality of Life (HQL) Scores | EQ-5D UV, At W0 DoT | 0.823 Scores on a scale | Standard Deviation 0.189 |
| Placebo Group | Health-related Quality of Life (HQL) Scores | EQ-5D UV, At W0 DpT | 0.838 Scores on a scale | Standard Deviation 0.177 |
| Placebo Group | Health-related Quality of Life (HQL) Scores | EQ-5D UV, At W6 DpT | 0.835 Scores on a scale | Standard Deviation 0.176 |
| Placebo Group | Health-related Quality of Life (HQL) Scores | EQ-5D UV, At W12 DoT | 0.811 Scores on a scale | Standard Deviation 0.236 |
| Placebo Group | Health-related Quality of Life (HQL) Scores | EQ-5D UV, At M9 | 0.81 Scores on a scale | Standard Deviation 0.219 |
| Placebo Group | Health-related Quality of Life (HQL) Scores | EQ-5D UV, At M12 | 0.824 Scores on a scale | Standard Deviation 0.214 |
| Placebo Group | Health-related Quality of Life (HQL) Scores | EQ-5D UV, At M24 | 0.865 Scores on a scale | Standard Deviation 0.145 |
| Placebo Group | Health-related Quality of Life (HQL) Scores | EQ-5D UV, At W6 DoT | 0.825 Scores on a scale | Standard Deviation 0.191 |
| Placebo Group | Health-related Quality of Life (HQL) Scores | EQ-5D UV, At M6 | 0.825 Scores on a scale | Standard Deviation 0.236 |
| Placebo Group | Health-related Quality of Life (HQL) Scores | EQ-5D UV, At recurrence | 0.785 Scores on a scale | Standard Deviation 0.159 |
| Placebo Group | Health-related Quality of Life (HQL) Scores | EQ-5D UV, At 6M post W120 | 0.679 Scores on a scale | Standard Deviation 0.073 |
| Placebo Group | Health-related Quality of Life (HQL) Scores | EQ-5D UV, At 12M post W120 | 0.777 Scores on a scale | Standard Deviation 0.395 |
Secondary
Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the CT Population
DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence \[any tumor arising in contralateral lung or outside hemithorax\]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. Median DFS KMEs in % were obtained non-parametrically by Kaplan-Meier method and confidence intervals (CIs) calculated using the Greenwood formula for standard error computation.
Time frame: KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment. Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK1572932 Group | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the CT Population | DFS KME at 2Y - CT Population | 65.17 percent probability |
| GSK1572932 Group | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the CT Population | DFS KME at 3Y - CT Population | 60.39 percent probability |
| GSK1572932 Group | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the CT Population | DFS KME at 5Y - CT Population | 53.64 percent probability |
| GSK1572932 Group | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the CT Population | DFS KME at 4Y - CT Population | 58.17 percent probability |
| Placebo Group | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the CT Population | DFS KME at 4Y - CT Population | 59.3 percent probability |
| Placebo Group | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the CT Population | DFS KME at 2Y - CT Population | 66.94 percent probability |
| Placebo Group | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the CT Population | DFS KME at 5Y - CT Population | 54.8 percent probability |
| Placebo Group | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the CT Population | DFS KME at 3Y - CT Population | 63.09 percent probability |
Secondary
Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the No-CT Population
DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence \[any tumor arising in contralateral lung or outside hemithorax\]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. Median DFS KMEs in % were obtained non-parametrically by Kaplan-Meier method and confidence intervals (CIs) calculated using the Greenwood formula for standard error computation.
Time frame: KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK1572932 Group | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the No-CT Population | DFS KME at 2Y - No-CT Population | 66.03 percent probability |
| GSK1572932 Group | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the No-CT Population | DFS KME at 3Y - No-CT Population | 59.6 percent probability |
| GSK1572932 Group | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the No-CT Population | DFS KME at 5Y - No-CT Population | 49.72 percent probability |
| GSK1572932 Group | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the No-CT Population | DFS KME at 4Y - No-CT Population | 55.4 percent probability |
| Placebo Group | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the No-CT Population | DFS KME at 4Y - No-CT Population | 54.85 percent probability |
| Placebo Group | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the No-CT Population | DFS KME at 2Y - No-CT Population | 63.96 percent probability |
| Placebo Group | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the No-CT Population | DFS KME at 5Y - No-CT Population | 44.59 percent probability |
| Placebo Group | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the No-CT Population | DFS KME at 3Y - No-CT Population | 57.62 percent probability |
Secondary
Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the Overall Population
DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence \[any tumor arising in contralateral lung or outside hemithorax\]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. Median DFS KMEs in % were obtained non-parametrically by Kaplan-Meier method and confidence intervals (CIs) calculated using the Greenwood formula for standard error computation.
Time frame: KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment. Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| GSK1572932 Group | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the Overall Population | DFS KME at 2Y - Overall Population | 65.57 percent probability |
| GSK1572932 Group | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the Overall Population | DFS KME at 3Y - Overall Population | 59.97 percent probability |
| GSK1572932 Group | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the Overall Population | DFS KME at 4Y - Overall Population | 56.72 percent probability |
| GSK1572932 Group | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the Overall Population | DFS KME at 5Y - Overall Population | 51.73 percent probability |
| Placebo Group | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the Overall Population | DFS KME at 5Y - Overall Population | 49.56 percent probability |
| Placebo Group | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the Overall Population | DFS KME at 2Y - Overall Population | 65.5 percent probability |
| Placebo Group | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the Overall Population | DFS KME at 4Y - Overall Population | 57.19 percent probability |
| Placebo Group | Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the Overall Population | DFS KME at 3Y - Overall Population | 60.42 percent probability |
Secondary
Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR)
A seropositive/seronegative subject for anti-MAGE-A3 antibodies was a subject with anti-MAGE-A3 antibodies \>=/\< the seropositivity cut-off of 27 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL). A humoral responder as regards anti-MAGE-A3 antibodies was defined as 1) for initially seronegative patients, a patient with post-administration Anti-MAGE-A3 antibody concentration \>= 27 EL.U/mL; 2) for initially seropositive patients: post-treatment administration antibody concentration \>= 2 fold the pre-treatment antibody concentration.
Time frame: At Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)
Population: The According-To-Protocol (ATP) population for immunogenicity including all evaluable patients (meeting all eligibility criteria, complying with protocol defined procedures and intervals, with no elimination criteria during the study) who received at least the 4 first doses and for whom data were available for the considered assay and time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1572932 Group | Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR) | Anti-MAGE-A3 HR, W12 | 916 Participants |
| GSK1572932 Group | Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR) | Anti-MAGE-A3 HR, M9 | 627 Participants |
| GSK1572932 Group | Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR) | Anti-MAGE-A3 HR, M12 | 534 Participants |
| GSK1572932 Group | Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR) | Anti-MAGE-A3 HR, M18 | 417 Participants |
| GSK1572932 Group | Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR) | Anti-MAGE-A3 HR, M30 | 380 Participants |
| GSK1572932 Group | Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR) | Anti-MAGE-A3 HR, W6 | 922 Participants |
| GSK1572932 Group | Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR) | Anti-MAGE-A3 HR, at 12M post W120 | 75 Participants |
| Placebo Group | Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR) | Anti-MAGE-A3 HR, W12 | 15 Participants |
| Placebo Group | Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR) | Anti-MAGE-A3 HR, M30 | 8 Participants |
| Placebo Group | Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR) | Anti-MAGE-A3 HR, M9 | 13 Participants |
| Placebo Group | Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR) | Anti-MAGE-A3 HR, at 12M post W120 | 3 Participants |
| Placebo Group | Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR) | Anti-MAGE-A3 HR, M12 | 6 Participants |
| Placebo Group | Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR) | Anti-MAGE-A3 HR, W6 | 10 Participants |
| Placebo Group | Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR) | Anti-MAGE-A3 HR, M18 | 7 Participants |
Secondary
Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR)
A seropositive/seronegative subject for anti-PD antibodies was a subject with anti-PD antibodies ≥/\< the seropositivity cut-off of 100 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL). A humoral responder as regards anti-PD antibodies was defined as 1) for initially seronegative patients, a patient with post-administration anti-PD antibody concentration ≥ 100 EL.U/mL; 2) for initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration.
Time frame: At Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)
Population: The According-To-Protocol (ATP) population for immunogenicity including all evaluable patients (meeting all eligibility criteria, complying with protocol defined procedures and intervals, with no elimination criteria during the study) who received at least the 4 first doses and for whom data were available for the considered assay and time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1572932 Group | Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR) | Anti-PD HR, M9 | 575 Participants |
| GSK1572932 Group | Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR) | Anti-PD HR, M18 | 370 Participants |
| GSK1572932 Group | Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR) | Anti-PD HR, W12 | 853 Participants |
| GSK1572932 Group | Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR) | Anti-PD HR, M30 | 352 Participants |
| GSK1572932 Group | Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR) | Anti-PD HR, M12 | 479 Participants |
| GSK1572932 Group | Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR) | Anti-PD HR, at 12M post W120 | 77 Participants |
| GSK1572932 Group | Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR) | Anti-PD HR, W6 | 945 Participants |
| Placebo Group | Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR) | Anti-PD HR, at 12M post W120 | 4 Participants |
| Placebo Group | Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR) | Anti-PD HR, W6 | 27 Participants |
| Placebo Group | Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR) | Anti-PD HR, W12 | 35 Participants |
| Placebo Group | Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR) | Anti-PD HR, M9 | 26 Participants |
| Placebo Group | Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR) | Anti-PD HR, M12 | 19 Participants |
| Placebo Group | Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR) | Anti-PD HR, M18 | 21 Participants |
| Placebo Group | Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR) | Anti-PD HR, M30 | 17 Participants |
Secondary
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
The status of each patient as regards ALT laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Time frame: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR UNK; DLP G0 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR UNK; DLP G1 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR UNK; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G1; DLP G0 | 34 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G1; DLP UNK | 4 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G2; DLP G0 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G2; DLP G1 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G2; DLP G2 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G2; DLP G3 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G2; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR UNK; DLP G2 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR UNK; DLP G3 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR UNK; DLP UNK | 3 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G0; DLP G0 | 1133 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G0; DLP G1 | 162 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G0; DLP G2 | 17 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G0; DLP G3 | 7 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G0; DLP G4 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G0; DLP UNK | 113 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G1; DLP G1 | 32 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G1; DLP G2 | 4 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G1; DLP G3 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G1; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G2; DLP UNK | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G1; DLP G1 | 17 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR UNK; DLP G0 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G0; DLP G0 | 588 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G2; DLP G1 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR UNK; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G0; DLP G1 | 77 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G1; DLP G0 | 14 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G1; DLP G2 | 3 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G1; DLP UNK | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G0; DLP G2 | 8 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G2; DLP G0 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G2; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G0; DLP G3 | 7 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G2; DLP G2 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G1; DLP G3 | 2 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G2; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G0; DLP G4 | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR UNK; DLP G1 | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G2; DLP UNK | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR UNK; DLP G2 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G0; DLP UNK | 37 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR UNK; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR G1; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | ALT - SCR UNK; DLP UNK | 1 Participants |
Secondary
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
The status of each patient as regards AST laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Time frame: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G2; DLP G3 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR UNK; DLP G3 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR UNK; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G1; DLP G3 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G1; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G2; DLP G2 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR UNK; DLP G2 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G2; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G2; DLP UNK | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR UNK; DLP G0 | 12 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR UNK; DLP G1 | 5 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR UNK; DLP UNK | 5 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G0; DLP G0 | 1170 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G0; DLP G1 | 136 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G0; DLP G2 | 6 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G0; DLP G3 | 8 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G0; DLP G4 | 2 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G0; DLP UNK | 111 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G1; DLP G0 | 26 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G1; DLP G1 | 25 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G1; DLP G2 | 5 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G1; DLP UNK | 2 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G2; DLP G0 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G2; DLP G1 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G1; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR UNK; DLP G2 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G0; DLP G0 | 579 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR UNK; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G1; DLP G0 | 19 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G2; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G0; DLP G1 | 84 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G1; DLP G3 | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G2; DLP G0 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G2; DLP G1 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G0; DLP G2 | 4 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G2; DLP G2 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G1; DLP G1 | 16 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G0; DLP G3 | 5 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G2; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G1; DLP UNK | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G2; DLP UNK | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G0; DLP G4 | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR UNK; DLP G0 | 4 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G1; DLP G2 | 2 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR UNK; DLP G1 | 2 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR UNK; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR G0; DLP UNK | 37 Participants |
| Placebo Group | Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade | AST - SCR UNK; DLP UNK | 2 Participants |
Secondary
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
The status of each patient as regards ALKP laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Time frame: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1572932 Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR UNK; DLP G1 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G0; DLP G0 | 1121 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G0; DLP G3 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G2; DLP G0 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G0; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G2; DLP G3 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G0; DLP UNK | 107 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G0; DLP G2 | 3 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G1; DLP G0 | 63 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G2; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G1; DLP G1 | 79 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR UNK; DLP G2 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G1; DLP G2 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G1; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR UNK; DLP G3 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G1; DLP UNK | 11 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G0; DLP G1 | 99 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR UNK; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G2; DLP G1 | 2 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G1; DLP G3 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G2; DLP G2 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR UNK; DLP UNK | 5 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G2; DLP UNK | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR UNK; DLP G0 | 21 Participants |
| Placebo Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G2; DLP UNK | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR UNK; DLP G0 | 3 Participants |
| Placebo Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR UNK; DLP G1 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR UNK; DLP G2 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G0; DLP G0 | 569 Participants |
| Placebo Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G0; DLP G1 | 63 Participants |
| Placebo Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G0; DLP G2 | 2 Participants |
| Placebo Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G1; DLP G2 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G1; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G2; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G2; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR UNK; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR UNK; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR UNK; DLP UNK | 3 Participants |
| Placebo Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G0; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G0; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G0; DLP UNK | 39 Participants |
| Placebo Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G1; DLP G0 | 35 Participants |
| Placebo Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G1; DLP G1 | 38 Participants |
| Placebo Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G1; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G1; DLP UNK | 4 Participants |
| Placebo Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G2; DLP G0 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G2; DLP G1 | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade | ALKP - SCR G2; DLP G2 | 0 Participants |
Secondary
Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade
The status of each patient as regards BIL laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0) and G1. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Time frame: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1572932 Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR G0; DLP G4 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR UNK; DLP UNK | 4 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR G0; DLP G2 | 11 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR G0; DLP G0 | 1275 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR G0; DLP UNK | 114 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR G0; DLP G1 | 74 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR G1; DLP G0 | 10 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR UNK; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR G1; DLP G1 | 8 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR UNK; DLP G0 | 9 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR G1; DLP G2 | 5 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR G0; DLP G3 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR G1; DLP G3 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR UNK; DLP G3 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR G1; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR UNK; DLP G2 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR G1; DLP UNK | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR UNK; DLP G1 | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR G1; DLP UNK | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR UNK; DLP G2 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR UNK; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR G0; DLP G1 | 28 Participants |
| Placebo Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR G0; DLP G2 | 9 Participants |
| Placebo Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR G0; DLP G3 | 2 Participants |
| Placebo Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR G0; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR G0; DLP UNK | 37 Participants |
| Placebo Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR UNK; DLP G0 | 2 Participants |
| Placebo Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR UNK; DLP G1 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR UNK; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR UNK; DLP UNK | 2 Participants |
| Placebo Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR G0; DLP G0 | 661 Participants |
| Placebo Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR G1; DLP G0 | 5 Participants |
| Placebo Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR G1; DLP G1 | 9 Participants |
| Placebo Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR G1; DLP G2 | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR G1; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade | BIL - SCR G1; DLP G4 | 0 Participants |
Secondary
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
The status of each patient as regards CREA laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Time frame: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1572932 Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR UNK; DLP G3 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR UNK; DLP G1 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR UNK; DLP G2 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G0; DLP G2 | 3 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G0; DLP G3 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G1; DLP G3 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR UNK; DLP G0 | 2 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR UNK; DLP G4 | 2 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR UNK; DLP UNK | 1139 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G0; DLP G0 | 126 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G0; DLP G1 | 9 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G0; DLP G4 | 103 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G0; DLP UNK | 27 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G1; DLP G0 | 72 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G1; DLP G1 | 11 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G1; DLP G2 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G1; DLP G4 | 6 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G1; DLP UNK | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G2; DLP G0 | 7 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G2; DLP G1 | 6 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G2; DLP G2 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G2; DLP G3 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G2; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G2; DLP UNK | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G2; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G2; DLP G0 | 2 Participants |
| Placebo Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR UNK; DLP G1 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G1; DLP G0 | 44 Participants |
| Placebo Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G2; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G0; DLP G2 | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G1; DLP G1 | 6 Participants |
| Placebo Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G0; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G0; DLP UNK | 14 Participants |
| Placebo Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G2; DLP G1 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G1; DLP G2 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR UNK; DLP G2 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR UNK; DLP G0 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR UNK; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G1; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR UNK; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G2; DLP UNK | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR UNK; DLP UNK | 577 Participants |
| Placebo Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G1; DLP G4 | 4 Participants |
| Placebo Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G0; DLP G0 | 74 Participants |
| Placebo Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G2; DLP G2 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G0; DLP G1 | 3 Participants |
| Placebo Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G1; DLP UNK | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | CREA - SCR G0; DLP G4 | 32 Participants |
Secondary
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
The status of each patient as regards HGB laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Time frame: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G0; DLP G3 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G3; DLP G3 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G0; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G0; DLP UNK | 50 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR UNK; DLP G0 | 3 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G1; DLP G0 | 342 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR UNK; DLP G2 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G1; DLP G1 | 310 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR UNK; DLP G1 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G1; DLP G2 | 17 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G3; DLP G0 | 2 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G1; DLP G3 | 6 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR UNK; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G1; DLP G4 | 2 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G2; DLP G2 | 12 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G1; DLP UNK | 49 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR UNK; DLP UNK | 3 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G2; DLP G0 | 29 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G3; DLP G1 | 3 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G2; DLP G1 | 63 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G0; DLP G0 | 534 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G2; DLP G4 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR UNK; DLP G3 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G2; DLP UNK | 6 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G0; DLP G1 | 70 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G3; DLP G2 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G3; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G0; DLP G2 | 9 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G3; DLP UNK | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G2; DLP G3 | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G3; DLP UNK | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR UNK; DLP G2 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G0; DLP G4 | 2 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G2; DLP G2 | 3 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G2; DLP G3 | 3 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G3; DLP G0 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G3; DLP G1 | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G3; DLP G2 | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR UNK; DLP G0 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR UNK; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR UNK; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR UNK; DLP UNK | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G0; DLP G0 | 274 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G0; DLP G1 | 26 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G0; DLP G2 | 5 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G0; DLP G3 | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G0; DLP UNK | 19 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G1; DLP G0 | 187 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G1; DLP G1 | 142 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G1; DLP G2 | 14 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G1; DLP G3 | 3 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G1; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G1; DLP UNK | 15 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G2; DLP G0 | 30 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G2; DLP G1 | 31 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G2; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G2; DLP UNK | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G3; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR G3; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade | HGB - SCR UNK; DLP G1 | 0 Participants |
Secondary
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
The status of each patient as regards LEU laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Time frame: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR UNK; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G1; DLP G0 | 54 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G0; DLP G3 | 2 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G1; DLP UNK | 4 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G0; DLP G4 | 6 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G0; DLP G2 | 4 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G0; DLP UNK | 98 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR UNK; DLP UNK | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G1; DLP G2 | 2 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G2; DLP G1 | 3 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G2; DLP G0 | 13 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G2; DLP G2 | 2 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G1; DLP G1 | 21 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G2; DLP G3 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G2; DLP UNK | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G2; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR UNK; DLP G0 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G0; DLP G1 | 45 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G3; DLP G0 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR UNK; DLP G1 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G3; DLP G1 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G1; DLP G3 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G3; DLP G2 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR UNK; DLP G2 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G3; DLP G3 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G0; DLP G0 | 1259 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G3; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR UNK; DLP G3 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G3; DLP UNK | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G1; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G1; DLP G1 | 5 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR UNK; DLP UNK | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G0; DLP G0 | 652 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G0; DLP G1 | 29 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G0; DLP G2 | 2 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G0; DLP UNK | 32 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G1; DLP G0 | 24 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G1; DLP G2 | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G1; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G1; DLP G4 | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G1; DLP UNK | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G2; DLP G0 | 6 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR UNK; DLP G0 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR UNK; DLP G1 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR UNK; DLP G2 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR UNK; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR UNK; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G0; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G0; DLP G4 | 2 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G2; DLP G1 | 2 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G2; DLP G2 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G2; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G2; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G2; DLP UNK | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G3; DLP G0 | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G3; DLP G1 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G3; DLP G2 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G3; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G3; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | LEU - SCR G3; DLP UNK | 0 Participants |
Secondary
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
The status of each patient as regards LYM laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Time frame: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G2; DLP UNK | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G1; DLP G4 | 2 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G3; DLP G0 | 4 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G1; DLP G2 | 15 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G3; DLP G1 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G1; DLP UNK | 20 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G3; DLP G2 | 3 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G1; DLP G0 | 47 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G3; DLP G3 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G2; DLP G0 | 3 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G3; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G0; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G3; DLP UNK | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G2; DLP G1 | 7 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR UNK; DLP G0 | 12 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G1; DLP G1 | 86 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR UNK; DLP G1 | 3 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G2; DLP G2 | 4 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR UNK; DLP G2 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G0; DLP G3 | 5 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR UNK; DLP G3 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G2; DLP G3 | 2 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR UNK; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G1; DLP G3 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR UNK; DLP UNK | 4 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G2; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G0; DLP G0 | 999 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G0; DLP UNK | 96 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G0; DLP G1 | 160 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G0; DLP G2 | 40 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G0; DLP G1 | 89 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G1; DLP G1 | 42 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G0; DLP G2 | 16 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G0; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G0; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G0; DLP UNK | 35 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G1; DLP G0 | 27 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G1; DLP G2 | 4 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G1; DLP G3 | 4 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G1; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G1; DLP UNK | 5 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G2; DLP G0 | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G2; DLP G1 | 2 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G2; DLP G2 | 3 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G2; DLP G3 | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G2; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G2; DLP UNK | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G3; DLP G0 | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G3; DLP G1 | 2 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G3; DLP G2 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G3; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G3; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G3; DLP UNK | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR UNK; DLP G0 | 3 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR UNK; DLP G1 | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR UNK; DLP G2 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR UNK; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR UNK; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR UNK; DLP UNK | 2 Participants |
| Placebo Group | Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade | LYM - SCR G0; DLP G0 | 518 Participants |
Secondary
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
The status of each patient as regards NEU laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2, G3 and G4. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Time frame: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G2; DLP G0 | 32 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR UNK; DLP UNK | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G2; DLP G1 | 5 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G0; DLP G4 | 3 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G2; DLP G2 | 2 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR UNK; DLP G3 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G2; DLP G3 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G0; DLP UNK | 111 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G2; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G0; DLP G0 | 1200 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G2; DLP UNK | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G1; DLP G0 | 56 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G3; DLP G0 | 3 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR UNK; DLP G2 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G3; DLP G1 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G1; DLP G1 | 31 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G3; DLP G2 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G0; DLP G1 | 47 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G1; DLP G2 | 3 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G3; DLP G3 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR UNK; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G3; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G1; DLP G3 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G3; DLP UNK | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G0; DLP G2 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G4; DLP G0 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G1; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G4; DLP G1 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR UNK; DLP G1 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G4; DLP G2 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G4; DLP G3 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G1; DLP UNK | 3 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G4; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G0; DLP G3 | 2 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G4; DLP UNK | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR UNK; DLP G0 | 12 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G4; DLP UNK | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR UNK; DLP G0 | 3 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR UNK; DLP G1 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR UNK; DLP G2 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR UNK; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR UNK; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR UNK; DLP UNK | 2 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G0; DLP G0 | 625 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G0; DLP G1 | 28 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G0; DLP G2 | 3 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G0; DLP G3 | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G0; DLP G4 | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G0; DLP UNK | 37 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G1; DLP G0 | 23 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G1; DLP G1 | 10 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G1; DLP G2 | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G1; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G1; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G1; DLP UNK | 2 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G2; DLP G0 | 16 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G2; DLP G1 | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G2; DLP G2 | 2 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G2; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G2; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G2; DLP UNK | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G3; DLP G0 | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G3; DLP G1 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G3; DLP G2 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G4; DLP G2 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G3; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G3; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G3; DLP UNK | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G4; DLP G0 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G4; DLP G1 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G4; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | NEU - SCR G4; DLP G4 | 0 Participants |
Secondary
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
The status of each patient as regards PLA laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Time frame: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1572932 Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G0; DLP UNK | 98 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR UNK; DLP G1 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G1; DLP G0 | 22 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR UNK; DLP UNK | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G1; DLP G1 | 17 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G3; DLP UNK | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G1; DLP G2 | 2 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G0; DLP G0 | 1275 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G1; DLP G3 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR UNK; DLP G2 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G1; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G0; DLP G1 | 78 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G1; DLP UNK | 5 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G0; DLP G2 | 6 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G3; DLP G0 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR UNK; DLP G3 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G3; DLP G1 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G0; DLP G3 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G3; DLP G2 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR UNK; DLP G0 | 1 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G3; DLP G3 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G0; DLP G4 | 7 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G3; DLP G4 | 0 Participants |
| GSK1572932 Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR UNK; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G3; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G3; DLP UNK | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR UNK; DLP G1 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR UNK; DLP G2 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR UNK; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR UNK; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR UNK; DLP UNK | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G0; DLP G0 | 648 Participants |
| Placebo Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G0; DLP G1 | 38 Participants |
| Placebo Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G0; DLP G2 | 2 Participants |
| Placebo Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G0; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G0; DLP G4 | 2 Participants |
| Placebo Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G0; DLP UNK | 35 Participants |
| Placebo Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G1; DLP G0 | 16 Participants |
| Placebo Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G1; DLP G1 | 10 Participants |
| Placebo Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G1; DLP G2 | 4 Participants |
| Placebo Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G1; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G1; DLP G4 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G1; DLP UNK | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G3; DLP G0 | 1 Participants |
| Placebo Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G3; DLP G1 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G3; DLP G2 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR G3; DLP G3 | 0 Participants |
| Placebo Group | Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade | PLA - SCR UNK; DLP G0 | 1 Participants |
Secondary
Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP)
An AE was any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs reported are here below tabulated irrespective of grade, as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1), G2, G3, G4 and G5. Any here below is defined as irrespective of CTC grade reported.
Time frame: Within the 31-day follow-up period post treatment administration, up to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1572932 Group | Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP) | Patients with any AEs | 1369 Participants |
| GSK1572932 Group | Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP) | Patients with G1 AEs | 563 Participants |
| GSK1572932 Group | Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP) | Patients with G2 AEs | 560 Participants |
| GSK1572932 Group | Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP) | Patients with G3 AEs | 184 Participants |
| GSK1572932 Group | Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP) | Patients with G4 AEs | 49 Participants |
| GSK1572932 Group | Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP) | Patients with G5 AEs | 13 Participants |
| Placebo Group | Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP) | Patients with G4 AEs | 26 Participants |
| Placebo Group | Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP) | Patients with any AEs | 556 Participants |
| Placebo Group | Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP) | Patients with G3 AEs | 88 Participants |
| Placebo Group | Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP) | Patients with G1 AEs | 225 Participants |
| Placebo Group | Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP) | Patients with G5 AEs | 8 Participants |
| Placebo Group | Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP) | Patients with G2 AEs | 209 Participants |
Secondary
Number of Patients With Serious Adverse Events (SAEs) - Up to Data Lock Point (DLP)
A SAE is any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject, or was a Grade 4 AE according to CTC for Adverse Events, Version 3.0. Events part of natural course of lung cancer (i.e., disease progression, recurrence) were captured towards clinical efficacy assessment (CEA) and were not reported as SAEs. Death due to a progressive disease was similarly recorded towards CEA, but not as an SAE. However, if progression of lung cancer disease was greater than normally be expected, or if investigators considered that there was a causal relationship between treatment or protocol design/procedures and disease progression/ recurrence, then it was reported as SAE. Any new cancer (non-related to lung cancer) was reported as SAE.
Time frame: From screening (SCR) up to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| GSK1572932 Group | Number of Patients With Serious Adverse Events (SAEs) - Up to Data Lock Point (DLP) | 330 Participants |
| Placebo Group | Number of Patients With Serious Adverse Events (SAEs) - Up to Data Lock Point (DLP) | 164 Participants |
Secondary
Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+)
A seropositive subject for anti-MAGE-A3 antibodies was a subject with anti-MAGE-A3 antibodies \>= the seropositivity cut-off of 27 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL).
Time frame: Pre-treatment (PRE), at Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (At 12M post W120)
Population: The According-To-Protocol (ATP) population for immunogenicity including all evaluable patients (meeting all eligibility criteria, complying with protocol defined procedures and intervals, with no elimination criteria during the study) who received at least the 4 first doses and for whom data were available for the considered assay and time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1572932 Group | Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+) | Anti-MAGE-A3 S+, PRE | 105 Participants |
| GSK1572932 Group | Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+) | Anti-MAGE-A3 S+, W6 | 929 Participants |
| GSK1572932 Group | Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+) | Anti-MAGE-A3 S+, W12 | 921 Participants |
| GSK1572932 Group | Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+) | Anti-MAGE-A3 S+, M9 | 631 Participants |
| GSK1572932 Group | Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+) | Anti-MAGE-A3 S+, M12 | 536 Participants |
| GSK1572932 Group | Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+) | Anti-MAGE-A3 S+, M18 | 419 Participants |
| GSK1572932 Group | Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+) | Anti-MAGE-A3 S+, M30 | 383 Participants |
| GSK1572932 Group | Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+) | Anti-MAGE-A3 S+, at 12M post W120 | 75 Participants |
| Placebo Group | Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+) | Anti-MAGE-A3 S+, at 12M post W120 | 5 Participants |
| Placebo Group | Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+) | Anti-MAGE-A3 S+, PRE | 53 Participants |
| Placebo Group | Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+) | Anti-MAGE-A3 S+, M12 | 19 Participants |
| Placebo Group | Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+) | Anti-MAGE-A3 S+, W6 | 43 Participants |
| Placebo Group | Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+) | Anti-MAGE-A3 S+, M30 | 17 Participants |
| Placebo Group | Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+) | Anti-MAGE-A3 S+, W12 | 42 Participants |
| Placebo Group | Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+) | Anti-MAGE-A3 S+, M18 | 15 Participants |
| Placebo Group | Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+) | Anti-MAGE-A3 S+, M9 | 30 Participants |
Secondary
Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+)
A seropositive subject for anti-PD antibodies was a subject with anti-PD antibodies \>= the seropositivity cut-off of 100 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL).
Time frame: Pre-treatment (PRE), at Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)
Population: The According-To-Protocol (ATP) population for immunogenicity including all evaluable patients (meeting all eligibility criteria, complying with protocol defined procedures and intervals, with no elimination criteria during the study) who received at least the 4 first doses and for whom data were available for the considered assay and time point.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| GSK1572932 Group | Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+) | Anti-PD S+, W6 | 958 Participants |
| GSK1572932 Group | Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+) | Anti-PD S+, M18 | 375 Participants |
| GSK1572932 Group | Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+) | Anti-PD S+, M9 | 580 Participants |
| GSK1572932 Group | Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+) | Anti-PD S+, M30 | 357 Participants |
| GSK1572932 Group | Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+) | Anti-PD S+, W12 | 860 Participants |
| GSK1572932 Group | Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+) | Anti-PD S+, at 12M post W120 | 77 Participants |
| GSK1572932 Group | Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+) | Anti-PD S+, M12 | 483 Participants |
| GSK1572932 Group | Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+) | Anti-PD S+, PRE | 381 Participants |
| Placebo Group | Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+) | Anti-PD S+, M12 | 101 Participants |
| Placebo Group | Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+) | Anti-PD S+, W6 | 195 Participants |
| Placebo Group | Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+) | Anti-PD S+, W12 | 176 Participants |
| Placebo Group | Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+) | Anti-PD S+, M9 | 133 Participants |
| Placebo Group | Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+) | Anti-PD S+, PRE | 210 Participants |
| Placebo Group | Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+) | Anti-PD S+, M18 | 77 Participants |
| Placebo Group | Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+) | Anti-PD S+, M30 | 75 Participants |
| Placebo Group | Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+) | Anti-PD S+, at 12M post W120 | 17 Participants |
Secondary
Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the CT Population
DFSS was defined as the interval from randomization to the date of disease recurrence or death due to lung cancer. Patients who had died due to another cause than lung cancer were censored on their date of death and patients alive at the time of analysis were censored on the date of last assessment. Patients with no assessment post-randomization were censored on the date of randomization. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.
Time frame: Period of follow-up was from administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1572932 Group | Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the CT Population | 0.162 events/person-years |
| Placebo Group | Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the CT Population | 0.149 events/person-years |
Secondary
Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the No-CT Population
DFSS was defined as the interval from randomization to the date of disease recurrence or death due to lung cancer. Patients who had died due to another cause than lung cancer were censored on their date of death and patients alive at the time of analysis were censored on the date of last assessment. Patients with no assessment post-randomization were censored on the date of randomization. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.
Time frame: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1572932 Group | Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the No-CT Population | 0.155 events/person-years |
| Placebo Group | Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the No-CT Population | 0.159 events/person-years |
Secondary
Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the Overall Population
DFSS was defined as the interval from randomization to the date of disease recurrence or death due to lung cancer. Patients who had died due to another cause than lung cancer were censored on their date of death and patients alive at the time of analysis were censored on the date of last assessment. Patients with no assessment post-randomization were censored on the date of randomization. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.
Time frame: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1572932 Group | Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the Overall Population | 0.159 events/person-years |
| Placebo Group | Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the Overall Population | 0.154 events/person-years |
Secondary
Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the CT Population
DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence \[any tumor arising in contralateral lung or outside hemithorax\]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.
Time frame: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1572932 Group | Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the CT Population | 0.172 events/person-years |
| Placebo Group | Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the CT Population | 0.158 events/person-years |
Secondary
Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the CT Population
LCSS was defined as the time interval from randomization to the date of death due to lung cancer. Deaths due to other or unknown causes were censored at the date of death. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.
Time frame: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1572932 Group | Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the CT Population | 0.063 events/person-years |
| Placebo Group | Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the CT Population | 0.063 events/person-years |
Secondary
Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the No-CT Population
LCSS was defined as the time interval from randomization to the date of death due to lung cancer. Deaths due to other or unknown causes were censored at the date of death. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.
Time frame: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1572932 Group | Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the No-CT Population | 0.064 events/person-years |
| Placebo Group | Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the No-CT Population | 0.06 events/person-years |
Secondary
Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the Overall Population
LCSS was defined as the time interval from randomization to the date of death due to lung cancer. Deaths due to other or unknown causes were censored at the date of death. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.
Time frame: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1572932 Group | Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the Overall Population | 0.064 events/person-years |
| Placebo Group | Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the Overall Population | 0.061 events/person-years |
Secondary
Person Year Rate (PYAR) as Regards Overall-survival (OS) in the CT Population
OS was defined as the time interval from randomization to the date of death, irrespective of the cause of death. Patients still alive were censored at the last visit they were known to be alive. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.
Time frame: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1572932 Group | Person Year Rate (PYAR) as Regards Overall-survival (OS) in the CT Population | 0.08 events/person-years |
| Placebo Group | Person Year Rate (PYAR) as Regards Overall-survival (OS) in the CT Population | 0.076 events/person-years |
Secondary
Person Year Rate (PYAR) as Regards Overall-survival (OS) in the No-CT Population
OS was defined as the time interval from randomization to the date of death, irrespective of the cause of death. Patients still alive were censored at the last visit they were known to be alive. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.
Time frame: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1572932 Group | Person Year Rate (PYAR) as Regards Overall-survival (OS) in the No-CT Population | 0.084 events/person-years |
| Placebo Group | Person Year Rate (PYAR) as Regards Overall-survival (OS) in the No-CT Population | 0.086 events/person-years |
Secondary
Person Year Rate (PYAR) as Regards Overall-survival (OS) in the Overall Population
OS was defined as the time interval from randomization to the date of death, irrespective of the cause of death. Patients still alive were censored at the last visit they were known to be alive. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period \[in years\] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.
Time frame: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| GSK1572932 Group | Person Year Rate (PYAR) as Regards Overall-survival (OS) in the Overall Population | 0.082 events/person-years |
| Placebo Group | Person Year Rate (PYAR) as Regards Overall-survival (OS) in the Overall Population | 0.081 events/person-years |