Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2008-001301-42 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The clinical objective of this clinical trial is to examine the clinical activity in terms of tumor response and time to treatment failure of the immunotherapeutic product GSK2132231A when given to patients with unresectable and progressive metastatic cutaneous melanoma. The safety of the treatment will also be assessed just as its immunogenicity in terms of the humoral and cellular immune response induced by the GSK2132231A immunotherapeutic. Translational research objectives are to assess the effects of the study treatment in terms of various biological variables.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK2132231A Group | Experimental | Subjects, male or female, 18 years of age or older, received up to 24 doses of GSK2132231A intramuscularly in 4 cycles. In Cycle 1 (ending Week 13) 6 doses were administered at 2-week intervals; in Cycle 2 (ending Week 32) 6 doses at 3-week intervals; in Cycle 3 (ending Week 54) 4 doses at 6-week intervals and in Cycle 4 4 doses at 12-week intervals, starting 12 weeks after end of Cycle 3, followed by, after an interruption of treatment of 6 months, 4 doses at 24-week intervals. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunotherapeutic GSK2132231A | Biological | Administration by intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Objective Tumor Response (OR) to GSK2132231A Study Treatment | OR was defined as the best Overall Response (OR) in a patient. OR = Complete Response (CR) + Partial Response (PR). Responses were categorized as CR, PR, stable disease (SD), SD/PR, progressive disease (PD) and non-evaluable (NE). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by Magnetic-resonance imaging: Complete Response (CR) = disappearance of all target lesions; Partial Response (PR) = ≥30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD) = neither sufficient shrinkage to be PR, not sufficient increase to qualify for Progressive Disease (PD); PD = ≥20% increase in the sum of largest diameter for target lesions. Best objective response = PR or CR. Disease control = CR, or PR, or SD, or SD/PR. | From Pre-treatment (up to 4 weeks before first treatment) to study end (Year 4), each patient being censored out of the analysis at 1st report of disease progression in assessed lesions |
| Number of Patients With Mixed Response (MR) to GSK2132231A | Assessment was done based on a set of measurable lesions (MLs) identified at baseline as target lesions (TLs) and non-TLs (NTL) followed up until disease progression. MLs assessed for matching below MR definitions. If evaluability per RECIST: a) MR Type 1= at least (a.l.) 30% decrease in LD in a.l. one TL measured at baseline. Such response occurring in SD/PD status of LD of TL and without appearance of one or more new lesions (= SD/PD with TL regression); b) MR Type 2: appearance of one or more new lesions occurring in SD/PR status of LD of TL (= SD/PR with new lesion). If non-evaluability per RECIST (due to LD<20mm): a) MR Type 1 = a clear decrease in diameters occurring in a.l. one TL measured at baseline. Such response occurring in SD/PD status of LD of (baseline) TL and without appearance of one or more new lesions (= SD/PD with TL regression); b) MR Type 2 = appearance of one or more new lesions occurring in SD/PR status of LD of TL (= SD/PR with new lesion). | From Pre-treatment (up to 4 weeks before first treatment) to study end (Year 4), each patient being censored out of the analysis at 1st report of disease progression in assessed lesions |
| Time to Treatment Failure (TTF), by Gene Signature |
Not provided
Not provided
Inclusion Criteria:
The patient (male or female) has histologically proven, measurable metastatic cutaneous melanoma in one of the following stages according to the American Joint Committee on Cancer classification of 2002:
There has been documented progression of the patient's disease within the 12 weeks before the first administration of study treatment.
The patient presents at screening with at least 3 tumor lesions of diameter >= 0.5 mm.
Written informed consent has been obtained from the patient before the performance of any protocol-specific procedure.
The patient is >= 18 years of age at the time of signature of informed consent.
The patient's tumor shows expression of MAGE-A3 gene in at least one of the two tumor biopsies performed at baseline.
The patient's ECOG performance status is 0 or 1.
The patient has normal organ functions, as assessed by standard laboratory criteria.
If the patient is female, she must be of non-childbearing potential, 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 the entire study treatment period and for 2 months after completion of the treatment injection series.
In the view of the investigator, the patient can and will comply with the requirements of the protocol.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Brussels | 1090 | Belgium | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30094070 | Background | Baurain JF, Robert C, Mortier L, Neyns B, Grange F, Lebbe C, Ulloa-Montoya F, De Sousa Alves PM, Gillet M, Louahed J, Jarnjak S, Lehmann FF. Association of homogeneous inflamed gene signature with a better outcome in patients with metastatic melanoma treated with MAGE-A3 immunotherapeutic. ESMO Open. 2018 Jul 25;3(5):e000384. doi: 10.1136/esmoopen-2018-000384. eCollection 2018. |
| Label | URL |
|---|---|
| IPD for this study will be made available via the Clinical Study Data Request site. | View source |
Not provided
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
During the screening the following steps occurred: check for inclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | GSK2132231A Group | Subjects, male or female, 18 years of age or older, received up to 24 doses of GSK2132231A intramuscularly in 4 cycles. In Cycle 1 (ending Week 11) 6 doses were administered at 2-week intervals; in Cycle 2 (ending Week 30) 6 doses at 3-week intervals; in Cycle 3 (ending Week 52) 4 doses at 6-week intervals and in Cycle 4 4 doses at 12-week intervals, starting 12 weeks after end of Cycle 3, followed by, after an interruption of treatment of 6 months, 4 doses at 24-week intervals. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GSK2132231A Group | Subjects, male or female, 18 years of age or older, received up to 24 doses of GSK2132231A intramuscularly in 4 cycles. In Cycle 1 (ending Week 11) 6 doses were administered at 2-week intervals; in Cycle 2 (ending Week 30) 6 doses at 3-week intervals; in Cycle 3 (ending Week 52) 4 doses at 6-week intervals and in Cycle 4 4 doses at 12-week intervals, starting 12 weeks after end of Cycle 3, followed by, after an interruption of treatment of 6 months, 4 doses at 24-week intervals. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Objective Tumor Response (OR) to GSK2132231A Study Treatment | OR was defined as the best Overall Response (OR) in a patient. OR = Complete Response (CR) + Partial Response (PR). Responses were categorized as CR, PR, stable disease (SD), SD/PR, progressive disease (PD) and non-evaluable (NE). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by Magnetic-resonance imaging: Complete Response (CR) = disappearance of all target lesions; Partial Response (PR) = ≥30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD) = neither sufficient shrinkage to be PR, not sufficient increase to qualify for Progressive Disease (PD); PD = ≥20% increase in the sum of largest diameter for target lesions. Best objective response = PR or CR. Disease control = CR, or PR, or SD, or SD/PR. | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment | Posted | Count of Participants | Participants | From Pre-treatment (up to 4 weeks before first treatment) to study end (Year 4), each patient being censored out of the analysis at 1st report of disease progression in assessed lesions |
Unsolicited AEs during the 31-day post-vaccination (Days 0-30), SAEs during the entire study period (Day 0 - Year 4).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GSK2132231A Group | Patients planned to receive intramuscularly up to 24 doses of GSK2132231A (the study product), in 4 cycles. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorder | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Administration site pain | General disorders | MedDRA 18.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
Not provided
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D065309 | Atypical Squamous Cells of the Cervix |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
TTF was defined as withdrawal from treatment with the GSK2132231A study product due to disease progression or death. TTF analysis was performed using the non-parametric Kaplan-Meier method. |
| From Pre-treatment (up to 4 weeks before first treatment) to study end (Year 4), each patient being censored out of the analysis at 1st report of disease progression or death |
| Anti-MAGE-A3 Antibody Concentrations | Anti-MAGE-A3 antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per millilitre (EL.U/mL). A seropositive patient was defined as a patient whose anti-MAGE-A3 antibody concentration was greater than or equal to 27 EL.U/mL. D=Day W=Week | From Pre-treatment (up to 4 weeks before first treatment) to Concluding visit (CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion) |
| Number of Seroconverted Patients for Anti-MAGE-A3 | Seroconversion was defined as a concentration of antibodies assessed that was greater than the cut-off value for a patient whose concentration of such antibodies was below the cut-off level before the initiation of treatment. Seroconverted patients were those patients with anti-MAGE-A3 antibody concentrations ≥ 27 EL.U/mL. | From Pre-treatment (up to 4 weeks before first treatment) to Concluding visit (CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion) |
| Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies | For initially seronegative patients: post-administration antibody concentration ≥ 27 EL.U/mL For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration | From Day 2 to Concluding visit (CCL:at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion) |
| Geometric Mean Titers of Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization | This endpoint presents the geometric mean concentration, expressed in titers, of anti-MAGE-A3 specific CD4+ and CD8+ T-cells. These specific T-cells included the cluster of differentiation 4+ (CD4+) and CD8+ T-cells producing cytokines Tumor Necrosis Factor-alpha (TNF-α) and/or Interferon-gamma (INF-γ). | From Pre-treatment (up to 4 weeks before first treatment) to Concluding visit (CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion) |
| Number of Patients With CD4+ and CD8+ T Cell Frequency ≥ 1.24 Cut-off | A patient was considered as a cellular mediated immune (CMI) responder if there was an increased amount of antigen-specific T-cells after immunization as compared to the patient's baseline value. These specific T-cells included the cluster of differentiation 4+ (CD4+) and CD8+ T-cells producing cytokines Tumor Necrosis Factor-alpha (TNF-α) and/or Interferon-gamma (INF-γ). | From Pre-treatment (up to 4 weeks before first treatment) to Concluding visit (CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion) |
| Number of Patients With a Cellular Response (Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization) | A patient was considered as a cellular mediated immune (CMI) responder if there was an increased amount of antigen-specific T-cells after immunization as compared to the patient's baseline value. These specific T-cells included the cluster of differentiation 4+ (CD4+) and CD8+ T-cells producing cytokines Tumor Necrosis Factor-alpha (TNF-α) and/or Interferon-gamma (INF-γ). | From Week 5 to Concluding visit (CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion) |
| Number of Patients Reported With Antigen Specific Cancer Immunotherapeutics (ASCI)-Related grade3/4 Adverse Events (AEs) According to the Common Terminology Criteria (CTCAE) Version 3.0. | The assessed AEs were ASCI-related grade 3/4 adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. An unsolicited AE covers any untoward medical occurrence in a clinical investigation patient temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. AEs may include pre- or post-treatment events that occur as a result of protocol-mandated procedures (i.e. invasive procedures, modification of patient's previous therapeutic regimen). | Within the 31-day (Days 0-30) post-administration periods |
| Number of Patients Reported With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a patient, is a Grade 4 AE according to the CTCAE, version3.0. Events which were part of the natural course of the disease under study were captured as part of the clinical activity outcome variables in this study; therefore did not need to be reported as SAEs. Progression/recurrence of the tumor was recorded as part of the clinical assessment data collection, and deaths due to progressive disease was recorded on a specific form, but not as an SAE. However, if the investigator considered that there was a causal relationship between treatment or protocol design/procedures and the disease progression/recurrence, then the event was reported as an SAE. Any new primary cancer (non-related to the cancer under study) was reported as an SAE. | During the entire study period (from Day 0 to CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion |
| Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. ALT - SCR G0; SE G3 = ALT with no abnormality/normal value at screening and with Severe abnormality at study end]. | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
| Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. AST - SCR G0; SE G3 = AST with no abnormality/normal value at screening and with Severe abnormality at study end]. | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
| Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. ALK - SCR G0; SE G3 = ALK with no abnormality/normal value at screening and with Severe abnormality at study end]. | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
| Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. BIL - SCR G0; SE G3 = BIL with no abnormality/normal value at screening and with Severe abnormality at study end]. | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
| Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. CREA - SCR G0; SE G3 = CREA with no abnormality/normal value at screening and with Severe abnormality at study end]. | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
| Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. GGT - SCR G0; SE G3 = GGT with no abnormality/normal value at screening and with Severe abnormality at study end]. | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
| Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. HGB - SCR G0; SE G3 = HGB with no abnormality/normal value at screening and with Severe abnormality at study end]. | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
| Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. HCA - SCR G0; SE G3 = HCA with no abnormality/normal value at screening and with Severe abnormality at study end]. | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
| Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. HKA - SCR G0; SE G3 = HKA with no abnormality/normal value at screening and with Severe abnormality at study end]. | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
| Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. HNA - SCR G0; SE G3 = HNA with no abnormality/normal value at screening and with Severe abnormality at study end]. | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
| Number of Patients With Abnormal Hypoalbuminemia (hAL) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. hAL - SCR G0; SE G3 = hAL with no abnormality/normal value at screening and with Severe abnormality at study end]. | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
| Number of Patients With Abnormal Hypocalcemia (hCA) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. hCA - SCR G0; SE G3 = hCA with no abnormality/normal value at screening and with Severe abnormality at study end]. | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
| Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. hKA - SCR G0; SE G3 = hKA with no abnormality/normal value at screening and with Severe abnormality at study end]. | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
| Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. hNA - SCR G0; SE G3 = hNA with no abnormality/normal value at screening and with Severe abnormality at study end]. | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
| Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. LEU - SCR G0; SE G3 = LEU with no abnormality/normal value at screening and with Severe abnormality at study end]. | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
| Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. LYM - SCR G0; SE G3 = LYM with no abnormality/normal value at screening and with Severe abnormality at study end]. | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
| Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. NEU - SCR G0; SE G3 = NEU with no abnormality/normal value at screening and with Severe abnormality at study end]. | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
| Number of Patients With Abnormal Platelets (PLT) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. PLT - SCR G0; SE G3 = PLT with no abnormality/normal value at screening and with Severe abnormality at study end]. | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
| Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade | 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 (any), 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) - Mild AE, G2 - Moderate AE, G3 - Severe AE, G4 - Life threatening/Disabling AE and G5 - Death related to AE. | Within the 31-day (Day 0-30) follow-up period post treatment administration. |
| Number of Patients With Any AE(s) and With AEs by Maximum Grade, Related to Treatment Administration | 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 (any), 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) - Mild AE, G2 - Moderate AE, G3 - Severe AE, G4 - Life threatening/Disabling AE and G5 - Death related to AE. | Within the 31-day (Day 0-30) follow-up period post treatment administration. |
| Number of Patients With Any Serious Adverse Events (SAEs) and With SAEs by Maximum Grade | SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a patient. Events which were part of the natural course of the disease under study were captured as part of the clinical activity outcome variables in this study; therefore did not need to be reported as SAEs. Progression/recurrence of the tumor was recorded as part of the clinical assessment data collection, and deaths due to progressive disease was recorded on a specific form, but not as an SAE. SAEs reported are here below tabulated irrespective of grade (any), as well as graded by maximum grade reported according to the CTC Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1) - Mild SAE, G2 - Moderate SAE, G3 - Severe SAE, G4 - Life threatening/Disabling SAE and G5 - Death related to SAE. | Within the 31-day (Day 0-30) follow-up period post treatment administration. |
| Number of Patients With Any Serious Adverse Events (SAEs) and With SAEs by Maximum Grade, Related to Treatment Administration | SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a patient. Events which were part of the natural course of the disease under study were captured as part of the clinical activity outcome variables in this study; therefore did not need to be reported as SAEs. Progression/recurrence of the tumor was recorded as part of the clinical assessment data collection, and deaths due to progressive disease was recorded on a specific form, but not as an SAE. SAEs reported are here below tabulated irrespective of grade (any), as well as graded by maximum grade reported according to the CTC Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1) - Mild SAE, G2 - Moderate SAE, G3 - Severe SAE, G4 - Life threatening/Disabling SAE and G5 - Death related to SAE. | Within the 31-day (Day 0-30) follow-up period post treatment administration. |
| Brussels |
| 1200 |
| Belgium |
| GSK Investigational Site | Wilrijk | 2610 | Belgium |
| GSK Investigational Site | Caen | 14033 | France |
| GSK Investigational Site | Lille | 59037 | France |
| GSK Investigational Site | Paris | 75475 | France |
| GSK Investigational Site | Reims | 51092 | France |
| GSK Investigational Site | Villejuif | 94805 | France |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | GSK2132231A GS+/+ Group | Subset of subjects from the GSK2132231A Group having a gene signature positive for two biopsies, as assessed at screening. |
| OG001 | GSK2132231A GS+/- Group | Subset of subjects from the GSK2132231A Group having a gene signature positive for only one biopsies, as assessed at screening. |
| OG002 | GSK2132231A GS- Group | Subset of subjects from the GSK2132231A Group having a gene signature negative for both biopsies, as assessed at screening. |
|
|
| Primary | Number of Patients With Mixed Response (MR) to GSK2132231A | Assessment was done based on a set of measurable lesions (MLs) identified at baseline as target lesions (TLs) and non-TLs (NTL) followed up until disease progression. MLs assessed for matching below MR definitions. If evaluability per RECIST: a) MR Type 1= at least (a.l.) 30% decrease in LD in a.l. one TL measured at baseline. Such response occurring in SD/PD status of LD of TL and without appearance of one or more new lesions (= SD/PD with TL regression); b) MR Type 2: appearance of one or more new lesions occurring in SD/PR status of LD of TL (= SD/PR with new lesion). If non-evaluability per RECIST (due to LD<20mm): a) MR Type 1 = a clear decrease in diameters occurring in a.l. one TL measured at baseline. Such response occurring in SD/PD status of LD of (baseline) TL and without appearance of one or more new lesions (= SD/PD with TL regression); b) MR Type 2 = appearance of one or more new lesions occurring in SD/PR status of LD of TL (= SD/PR with new lesion). | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment | Posted | Count of Participants | Participants | From Pre-treatment (up to 4 weeks before first treatment) to study end (Year 4), each patient being censored out of the analysis at 1st report of disease progression in assessed lesions |
|
|
|
| Primary | Time to Treatment Failure (TTF), by Gene Signature | TTF was defined as withdrawal from treatment with the GSK2132231A study product due to disease progression or death. TTF analysis was performed using the non-parametric Kaplan-Meier method. | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment | Posted | Median | 95% Confidence Interval | Months | From Pre-treatment (up to 4 weeks before first treatment) to study end (Year 4), each patient being censored out of the analysis at 1st report of disease progression or death |
|
|
|
| Primary | Anti-MAGE-A3 Antibody Concentrations | Anti-MAGE-A3 antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per millilitre (EL.U/mL). A seropositive patient was defined as a patient whose anti-MAGE-A3 antibody concentration was greater than or equal to 27 EL.U/mL. D=Day W=Week | The ATP population for Immunogenicity included all eligible patients, who have received at least the first 6 GSK2132231A study treatment doses and have provided a result for Immunogenicity measurement within 2 weeks following Dose 6. | Posted | Geometric Mean | 95% Confidence Interval | EL.U/mL | From Pre-treatment (up to 4 weeks before first treatment) to Concluding visit (CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion) |
|
|
|
| Primary | Number of Seroconverted Patients for Anti-MAGE-A3 | Seroconversion was defined as a concentration of antibodies assessed that was greater than the cut-off value for a patient whose concentration of such antibodies was below the cut-off level before the initiation of treatment. Seroconverted patients were those patients with anti-MAGE-A3 antibody concentrations ≥ 27 EL.U/mL. | The ATP population for Immunogenicity included all eligible patients, who have received at least the first 6 GSK2132231A study treatment doses and have provided a result for Immunogenicity measurement within 2 weeks following Dose 6. | Posted | Count of Participants | Participants | From Pre-treatment (up to 4 weeks before first treatment) to Concluding visit (CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion) |
|
|
|
| Primary | Number of Patients With Treatment Response for Anti-MAGE-A3 Antibodies | For initially seronegative patients: post-administration antibody concentration ≥ 27 EL.U/mL For initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration | The ATP population for Immunogenicity included all eligible patients, who have received at least the first 6 GSK2132231A study treatment doses and have provided a result for Immunogenicity measurement within 2 weeks following Dose 6. | Posted | Count of Participants | Participants | From Day 2 to Concluding visit (CCL:at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion) |
|
|
|
| Primary | Geometric Mean Titers of Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization | This endpoint presents the geometric mean concentration, expressed in titers, of anti-MAGE-A3 specific CD4+ and CD8+ T-cells. These specific T-cells included the cluster of differentiation 4+ (CD4+) and CD8+ T-cells producing cytokines Tumor Necrosis Factor-alpha (TNF-α) and/or Interferon-gamma (INF-γ). | The ATP population for Immunogenicity included all eligible patients, who have received at least the first 6 GSK2132231A study treatment doses and have provided a result for Immunogenicity measurement within 2 weeks following Dose 6. | Posted | Geometric Mean | 95% Confidence Interval | Titers | From Pre-treatment (up to 4 weeks before first treatment) to Concluding visit (CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion) |
|
|
|
| Primary | Number of Patients With CD4+ and CD8+ T Cell Frequency ≥ 1.24 Cut-off | A patient was considered as a cellular mediated immune (CMI) responder if there was an increased amount of antigen-specific T-cells after immunization as compared to the patient's baseline value. These specific T-cells included the cluster of differentiation 4+ (CD4+) and CD8+ T-cells producing cytokines Tumor Necrosis Factor-alpha (TNF-α) and/or Interferon-gamma (INF-γ). | The ATP population for Immunogenicity included all eligible patients, who have received at least the first 6 GSK2132231A study treatment doses and have provided a result for Immunogenicity measurement within 2 weeks following Dose 6. | Posted | Count of Participants | Participants | From Pre-treatment (up to 4 weeks before first treatment) to Concluding visit (CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion) |
|
|
|
| Primary | Number of Patients With a Cellular Response (Anti-MAGE-A3 Specific CD4+ and CD8+ T-cells Concentrations After Immunization) | A patient was considered as a cellular mediated immune (CMI) responder if there was an increased amount of antigen-specific T-cells after immunization as compared to the patient's baseline value. These specific T-cells included the cluster of differentiation 4+ (CD4+) and CD8+ T-cells producing cytokines Tumor Necrosis Factor-alpha (TNF-α) and/or Interferon-gamma (INF-γ). | The ATP population for Immunogenicity included all eligible patients, who have received at least the first 6 GSK2132231A study treatment doses and have provided a result for Immunogenicity measurement within 2 weeks following Dose 6. | Posted | Count of Participants | Participants | From Week 5 to Concluding visit (CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion) |
|
|
|
| Primary | Number of Patients Reported With Antigen Specific Cancer Immunotherapeutics (ASCI)-Related grade3/4 Adverse Events (AEs) According to the Common Terminology Criteria (CTCAE) Version 3.0. | The assessed AEs were ASCI-related grade 3/4 adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. An unsolicited AE covers any untoward medical occurrence in a clinical investigation patient temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. AEs may include pre- or post-treatment events that occur as a result of protocol-mandated procedures (i.e. invasive procedures, modification of patient's previous therapeutic regimen). | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment. | Posted | Count of Participants | Participants | Within the 31-day (Days 0-30) post-administration periods |
|
|
|
| Primary | Number of Patients Reported With Serious Adverse Events (SAEs) | Serious adverse events (SAEs) include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a patient, is a Grade 4 AE according to the CTCAE, version3.0. Events which were part of the natural course of the disease under study were captured as part of the clinical activity outcome variables in this study; therefore did not need to be reported as SAEs. Progression/recurrence of the tumor was recorded as part of the clinical assessment data collection, and deaths due to progressive disease was recorded on a specific form, but not as an SAE. However, if the investigator considered that there was a causal relationship between treatment or protocol design/procedures and the disease progression/recurrence, then the event was reported as an SAE. Any new primary cancer (non-related to the cancer under study) was reported as an SAE. | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A ASCI study treatment. | Posted | Count of Participants | Participants | During the entire study period (from Day 0 to CCL: at Week 196 + 30 to 37 days for patients completing the treatment, 1 month after the last Dose administered for patients withdrawn from study treatment before completion |
|
|
|
| Primary | Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. ALT - SCR G0; SE G3 = ALT with no abnormality/normal value at screening and with Severe abnormality at study end]. | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment. | Posted | Count of Participants | Participants | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
|
|
|
| Primary | Number of Patients With Abnormal Aspartate Aminotransferase (AST) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. AST - SCR G0; SE G3 = AST with no abnormality/normal value at screening and with Severe abnormality at study end]. | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment. | Posted | Count of Participants | Participants | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
|
|
|
| Primary | Number of Patients With Abnormal Alkaline Phosphatase (ALK) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. ALK - SCR G0; SE G3 = ALK with no abnormality/normal value at screening and with Severe abnormality at study end]. | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment. | Posted | Count of Participants | Participants | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
|
|
|
| Primary | Number of Patients With Abnormal Bilirubine (BIL) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. BIL - SCR G0; SE G3 = BIL with no abnormality/normal value at screening and with Severe abnormality at study end]. | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment. | Posted | Count of Participants | Participants | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
|
|
|
| Primary | Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. CREA - SCR G0; SE G3 = CREA with no abnormality/normal value at screening and with Severe abnormality at study end]. | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment. | Posted | Count of Participants | Participants | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
|
|
|
| Primary | Number of Patients With Abnormal Gamma-glutamyl Transpeptidase (GGT) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. GGT - SCR G0; SE G3 = GGT with no abnormality/normal value at screening and with Severe abnormality at study end]. | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment. | Posted | Count of Participants | Participants | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
|
|
|
| Primary | Number of Patients With Abnormal Hemoglobin (HGB) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. HGB - SCR G0; SE G3 = HGB with no abnormality/normal value at screening and with Severe abnormality at study end]. | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment. | Posted | Count of Participants | Participants | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
|
|
|
| Primary | Number of Patients With Abnormal Hypercalcemia (HCA) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. HCA - SCR G0; SE G3 = HCA with no abnormality/normal value at screening and with Severe abnormality at study end]. | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment. | Posted | Count of Participants | Participants | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
|
|
|
| Primary | Number of Patients With Abnormal Hyperkalemia (HKA) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. HKA - SCR G0; SE G3 = HKA with no abnormality/normal value at screening and with Severe abnormality at study end]. | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment. | Posted | Count of Participants | Participants | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
|
|
|
| Primary | Number of Patients With Abnormal Hypernatremia (HNA) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. HNA - SCR G0; SE G3 = HNA with no abnormality/normal value at screening and with Severe abnormality at study end]. | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment. | Posted | Count of Participants | Participants | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
|
|
|
| Primary | Number of Patients With Abnormal Hypoalbuminemia (hAL) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. hAL - SCR G0; SE G3 = hAL with no abnormality/normal value at screening and with Severe abnormality at study end]. | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment. | Posted | Count of Participants | Participants | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
|
|
|
| Primary | Number of Patients With Abnormal Hypocalcemia (hCA) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. hCA - SCR G0; SE G3 = hCA with no abnormality/normal value at screening and with Severe abnormality at study end]. | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment. | Posted | Count of Participants | Participants | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
|
|
|
| Primary | Number of Patients With Abnormal Hypokalemia (hKA) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. hKA - SCR G0; SE G3 = hKA with no abnormality/normal value at screening and with Severe abnormality at study end]. | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment. | Posted | Count of Participants | Participants | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
|
|
|
| Primary | Number of Patients With Abnormal Hyponatremia (hNA) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. hNA - SCR G0; SE G3 = hNA with no abnormality/normal value at screening and with Severe abnormality at study end]. | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment. | Posted | Count of Participants | Participants | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
|
|
|
| Primary | Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. LEU - SCR G0; SE G3 = LEU with no abnormality/normal value at screening and with Severe abnormality at study end]. | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment. | Posted | Count of Participants | Participants | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
|
|
|
| Primary | Number of Patients With Abnormal Lymphopenia (LYM) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. LYM - SCR G0; SE G3 = LYM with no abnormality/normal value at screening and with Severe abnormality at study end]. | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment. | Posted | Count of Participants | Participants | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
|
|
|
| Primary | Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. NEU - SCR G0; SE G3 = NEU with no abnormality/normal value at screening and with Severe abnormality at study end]. | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment. | Posted | Count of Participants | Participants | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
|
|
|
| Primary | Number of Patients With Abnormal Platelets (PLT) Values by Maximum Grade | The status of each patient was collected and graded according to the Common Terminology Criteria Adverse Event (CTCAE v.03) terminology. Gradings were: G0 (normal value), G1 (Mild abnormality), G2 (Moderate abnormality), G3 (Severe abnormality), G4 (Life-threatening/Disabling abnormality), Unknown abnormality (UNK). The post-treatment values, at Study End (SE) were presented versus baseline values, at Screening (SCR). [e.g. PLT - SCR G0; SE G3 = PLT with no abnormality/normal value at screening and with Severe abnormality at study end]. | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment. | Posted | Count of Participants | Participants | From Screening and up to Week 11 (Cycle 1), Week 30 (Cycle 2), Week 52 (Cycle 3), and Study End at Year 4 (Cycle 4) |
|
|
|
| Primary | Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade | 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 (any), 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) - Mild AE, G2 - Moderate AE, G3 - Severe AE, G4 - Life threatening/Disabling AE and G5 - Death related to AE. | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment. | Posted | Count of Participants | Participants | Within the 31-day (Day 0-30) follow-up period post treatment administration. |
|
|
|
| Primary | Number of Patients With Any AE(s) and With AEs by Maximum Grade, Related to Treatment Administration | 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 (any), 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) - Mild AE, G2 - Moderate AE, G3 - Severe AE, G4 - Life threatening/Disabling AE and G5 - Death related to AE. | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment. | Posted | Count of Participants | Participants | Within the 31-day (Day 0-30) follow-up period post treatment administration. |
|
|
|
| Primary | Number of Patients With Any Serious Adverse Events (SAEs) and With SAEs by Maximum Grade | SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a patient. Events which were part of the natural course of the disease under study were captured as part of the clinical activity outcome variables in this study; therefore did not need to be reported as SAEs. Progression/recurrence of the tumor was recorded as part of the clinical assessment data collection, and deaths due to progressive disease was recorded on a specific form, but not as an SAE. SAEs reported are here below tabulated irrespective of grade (any), as well as graded by maximum grade reported according to the CTC Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1) - Mild SAE, G2 - Moderate SAE, G3 - Severe SAE, G4 - Life threatening/Disabling SAE and G5 - Death related to SAE. | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment. | Posted | Count of Participants | Participants | Within the 31-day (Day 0-30) follow-up period post treatment administration. |
|
|
|
| Primary | Number of Patients With Any Serious Adverse Events (SAEs) and With SAEs by Maximum Grade, Related to Treatment Administration | SAEs include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a patient. Events which were part of the natural course of the disease under study were captured as part of the clinical activity outcome variables in this study; therefore did not need to be reported as SAEs. Progression/recurrence of the tumor was recorded as part of the clinical assessment data collection, and deaths due to progressive disease was recorded on a specific form, but not as an SAE. SAEs reported are here below tabulated irrespective of grade (any), as well as graded by maximum grade reported according to the CTC Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1) - Mild SAE, G2 - Moderate SAE, G3 - Severe SAE, G4 - Life threatening/Disabling SAE and G5 - Death related to SAE. | The Total Treated population included all patients who have received at least one Dose of the GSK2132231A study treatment. | Posted | Count of Participants | Participants | Within the 31-day (Day 0-30) follow-up period post treatment administration. |
|
|
|
| 0 |
| 24 |
| 2 |
| 24 |
| 23 |
| 24 |
| Metastatic malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Discomfort | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Ulcer | General disorders | MedDRA 18.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002578 | Uterine Cervical Dysplasia |
| D011230 | Precancerous Conditions |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D065308 | Morphological and Microscopic Findings |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| Best response MR (SD/PR) |
|
| Best response MR (SD/PD) |
|
| Best response SD |
|
| Best response SD/PD |
|
| Best response PD (SPD) |
|
| Best response PD (SPD/MR) |
|
| Best response NE |
|
| Anti-MAGE-A3, D2 |
|
|
| Anti-MAGE-A3, D7 |
|
|
| Anti-MAGE-A3, D15 |
|
|
| Anti-MAGE-A3, D16 |
|
|
| Anti-MAGE-A3, W5 |
|
|
| Anti-MAGE-A3, W11 |
|
|
| Anti-MAGE-A3, W13 |
|
|
| Anti-MAGE-A3, W21 |
|
|
| Anti-MAGE-A3, W32 |
|
|
| Anti-MAGE-A3, W54 |
|
|
| Anti-MAGE-A3, W76 |
|
|
| Anti-MAGE-A3, W78 |
|
|
| Anti-MAGE-A3, W100 |
|
|
| Anti-MAGE-A3, W102 |
|
|
| Anti-MAGE-A3, W124 |
|
|
| Anti-MAGE-A3, W126 |
|
|
| Anti-MAGE-A3, W148 |
|
|
| Anti-MAGE-A3, W150 |
|
|
| Anti-MAGE-A3, W174 |
|
|
| Anti-MAGE-A3, CCL |
|
|
| Anti-MAGE-A3, D2 |
|
|
| Anti-MAGE-A3, D7 |
|
|
| Anti-MAGE-A3, D15 |
|
|
| Anti-MAGE-A3, D16 |
|
|
| Anti-MAGE-A3, W5 |
|
|
| Anti-MAGE-A3, W11 |
|
|
| Anti-MAGE-A3, W13 |
|
|
| Anti-MAGE-A3, W21 |
|
|
| Anti-MAGE-A3, W32 |
|
|
| Anti-MAGE-A3, W54 |
|
|
| Anti-MAGE-A3, W76 |
|
|
| Anti-MAGE-A3, W78 |
|
|
| Anti-MAGE-A3, W100 |
|
|
| Anti-MAGE-A3, W102 |
|
|
| Anti-MAGE-A3, W124 |
|
|
| Anti-MAGE-A3, W126 |
|
|
| Anti-MAGE-A3, W148 |
|
|
| Anti-MAGE-A3, W150 |
|
|
| Anti-MAGE-A3, W174 |
|
|
| Anti-MAGE-A3, CCL |
|
|
| Anti-MAGE-A3, D7 |
|
|
| Anti-MAGE-A3, D15 |
|
|
| Anti-MAGE-A3, D16 |
|
|
| Anti-MAGE-A3, W5 |
|
|
| Anti-MAGE-A3, W11 |
|
|
| Anti-MAGE-A3, W13 |
|
|
| Anti-MAGE-A3, W21 |
|
|
| Anti-MAGE-A3, W32 |
|
|
| Anti-MAGE-A3, W54 |
|
|
| Anti-MAGE-A3, W76 |
|
|
| Anti-MAGE-A3, W78 |
|
|
| Anti-MAGE-A3, W100 |
|
|
| Anti-MAGE-A3, W102 |
|
|
| Anti-MAGE-A3, W124 |
|
|
| Anti-MAGE-A3, W126 |
|
|
| Anti-MAGE-A3, W148 |
|
|
| Anti-MAGE-A3, W150 |
|
|
| Anti-MAGE-A3, W174 |
|
|
| Anti-MAGE-A3, CCL |
|
|
|
| CD4.TNFα (+) + IFNγ (+) W5 |
|
|
| CD8.TNFα (+) + IFNγ (+) W5 |
|
|
| CD4.TNFα (+) + IFNγ (+) W13 |
|
|
| CD8.TNFα (+) + IFNγ (+) W13 |
|
|
| CD4.TNFα (+) + IFNγ (+) W32 |
|
|
| CD8.TNFα (+) + IFNγ (+) W32 |
|
|
| CD4.TNFα (+) + IFNγ (+) W54 |
|
|
| CD8.TNFα (+) + IFNγ (+) W54 |
|
|
| CD4.TNFα (+) + IFNγ (+) W78 |
|
|
| CD8.TNFα (+) + IFNγ (+) W78 |
|
|
| CD4.TNFα (+) + IFNγ (+) W102 |
|
|
| CD8.TNFα (+) + IFNγ (+) W102 |
|
|
| CD4.TNFα (+) + IFNγ (+) CCL |
|
|
| CD8.TNFα (+) + IFNγ (+) CCL |
|
|
|
| CD4.TNFα (+) + IFNγ (+) W5 |
|
|
| CD8.TNFα (+) + IFNγ (+) W5 |
|
|
| CD4.TNFα (+) + IFNγ (+) W13 |
|
|
| CD8.TNFα (+) + IFNγ (+) W13 |
|
|
| CD4.TNFα (+) + IFNγ (+) W32 |
|
|
| CD8.TNFα (+) + IFNγ (+) W32 |
|
|
| CD4.TNFα (+) + IFNγ (+) W54 |
|
|
| CD8.TNFα (+) + IFNγ (+) W54 |
|
|
| CD4.TNFα (+) + IFNγ (+) W78 |
|
|
| CD8.TNFα (+) + IFNγ (+) W78 |
|
|
| CD4.TNFα (+) + IFNγ (+) W102 |
|
|
| CD8.TNFα (+) + IFNγ (+) W102 |
|
|
| CD4.TNFα (+) + IFNγ (+) CCL |
|
|
| CD8.TNFα (+) + IFNγ (+) CCL |
|
|
| CD4.TNFα (+) + IFNγ (+) At any time point |
|
|
| CD8.TNFα (+) + IFNγ (+) At any time point |
|
|
|
| CD4.TNFα (+) + IFNγ (+) W13 |
|
|
| CD8.TNFα (+) + IFNγ (+) W13 |
|
|
| CD4.TNFα (+) + IFNγ (+) W32 |
|
|
| CD8.TNFα (+) + IFNγ (+) W32 |
|
|
| CD4.TNFα (+) + IFNγ (+) W54 |
|
|
| CD8.TNFα (+) + IFNγ (+) W54 |
|
|
| CD4.TNFα (+) + IFNγ (+) W78 |
|
|
| CD8.TNFα (+) + IFNγ (+) W78 |
|
|
| CD4.TNFα (+) + IFNγ (+) W102 |
|
|
| CD8.TNFα (+) + IFNγ (+) W102 |
|
|
| CD4.TNFα (+) + IFNγ (+) CCL |
|
|
| CD8.TNFα (+) + IFNγ (+) CCL |
|
|
| CD4.TNFα (+) + IFNγ (+) At any time point |
|
|
| CD8.TNFα (+) + IFNγ (+) At any time point |
|
|
| Title | Measurements |
|---|---|
|
| ALT - SCR G0; SE G3 |
|
| ALT - SCR G0; SE G4 |
|
| ALT - SCR G0; SE UNK |
|
| Title | Measurements |
|---|---|
|
| AST - SCR G0; SE G3 |
|
| AST - SCR G0; SE G4 |
|
| AST - SCR G0; SE UNK |
|
| Title | Measurements |
|---|---|
|
| ALK - SCR UNK; SE G3 |
|
| ALK - SCR UNK; SE G4 |
|
| ALK - SCR UNK; SE UNK |
|
| ALK - SCR G0; SE G0 |
|
| ALK - SCR G0; SE G1 |
|
| ALK - SCR G0; SE G2 |
|
| ALK - SCR G0; SE G3 |
|
| ALK - SCR G0; SE G4 |
|
| ALK - SCR G0; SE UNK |
|
| Title | Measurements |
|---|---|
|
| BIL - SCR G0; SE G3 |
|
| BIL - SCR G0; SE G4 |
|
| BIL - SCR G0; SE UNK |
|
| Title | Measurements |
|---|---|
|
| CREA - SCR G0; SE G3 |
|
| CREA - SCR G0; SE G4 |
|
| CREA - SCR G0; SE UNK |
|
| CREA - SCR G1; SE G0 |
|
| CREA - SCR G1; SE G1 |
|
| CREA - SCR G1; SE G2 |
|
| CREA - SCR G1; SE G3 |
|
| CREA - SCR G1; SE G4 |
|
| CREA - SCR G1; SE UNK |
|
| Title | Measurements |
|---|---|
|
| GGT - SCR UNK; SE G3 |
|
| GGT - SCR UNK; SE G4 |
|
| GGT - SCR UNK; SE UNK |
|
| GGT - SCR G0; SE G0 |
|
| GGT - SCR G0; SE G1 |
|
| GGT - SCR G0; SE G2 |
|
| GGT - SCR G0; SE G3 |
|
| GGT - SCR G0; SE G4 |
|
| GGT - SCR G0; SE UNK |
|
| GGT - SCR G1; SE G0 |
|
| GGT - SCR G1; SE G1 |
|
| GGT - SCR G1; SE G2 |
|
| GGT - SCR G1; SE G3 |
|
| GGT - SCR G1; SE G4 |
|
| GGT - SCR G1; SE UNK |
|
| Title | Measurements |
|---|---|
|
| HGB - SCR G0; SE G3 |
|
| HGB - SCR G0; SE G4 |
|
| HGB - SCR G0; SE UNK |
|
| HGB - SCR G1; SE G0 |
|
| HGB - SCR G1; SE G1 |
|
| HGB - SCR G1; SE G2 |
|
| HGB - SCR G1; SE G3 |
|
| HGB - SCR G1; SE G4 |
|
| HGB - SCR G1; SE UNK |
|
| Title | Measurements |
|---|---|
|
| HCA - SCR UNK; SE G3 |
|
| HCA - SCR UNK; SE G4 |
|
| HCA - SCR UNK; SE UNK |
|
| HCA - SCR G0; SE G0 |
|
| HCA - SCR G0; SE G1 |
|
| HCA - SCR G0; SE G2 |
|
| HCA - SCR G0; SE G3 |
|
| HCA - SCR G0; SE G4 |
|
| HCA - SCR G0; SE UNK |
|
| HCA - SCR G1; SE G0 |
|
| HCA - SCR G1; SE G1 |
|
| HCA - SCR G1; SE G2 |
|
| HCA - SCR G1; SE G3 |
|
| HCA - SCR G1; SE G4 |
|
| HCA - SCR G1; SE UNK |
|
| Title | Measurements |
|---|---|
|
| HKA - SCR UNK; SE G3 |
|
| HKA - SCR UNK; SE G4 |
|
| HKA - SCR UNK; SE UNK |
|
| HKA - SCR G0; SE G0 |
|
| HKA - SCR G0; SE G1 |
|
| HKA - SCR G0; SE G2 |
|
| HKA - SCR G0; SE G3 |
|
| HKA - SCR G0; SE G4 |
|
| HKA - SCR G0; SE UNK |
|
| HKA - SCR G1; SE G0 |
|
| HKA - SCR G1; SE G1 |
|
| HKA - SCR G1; SE G2 |
|
| HKA - SCR G1; SE G3 |
|
| HKA - SCR G1; SE G4 |
|
| HKA - SCR G1; SE UNK |
|
| Title | Measurements |
|---|---|
|
| HNA - SCR UNK; SE G3 |
|
| HNA - SCR UNK; SE G4 |
|
| HNA - SCR UNK; SE UNK |
|
| HNA - SCR G0; SE G0 |
|
| HNA - SCR G0; SE G1 |
|
| HNA - SCR G0; SE G2 |
|
| HNA - SCR G0; SE G3 |
|
| HNA - SCR G0; SE G4 |
|
| HNA - SCR G0; SE UNK |
|
| Title | Measurements |
|---|---|
|
| hAL - SCR UNK; SE G3 |
|
| hAL - SCR UNK; SE G4 |
|
| hAL - SCR UNK; SE UNK |
|
| hAL - SCR G0; SE G0 |
|
| hAL - SCR G0; SE G1 |
|
| hAL - SCR G0; SE G2 |
|
| hAL - SCR G0; SE G3 |
|
| hAL - SCR G0; SE G4 |
|
| hAL - SCR G0; SE UNK |
|
| Title | Measurements |
|---|---|
|
| hCA - SCR UNK; SE G3 |
|
| hCA - SCR UNK; SE G4 |
|
| hCA - SCR UNK; SE UNK |
|
| hCA - SCR G0; SE G0 |
|
| hCA - SCR G0; SE G1 |
|
| hCA - SCR G0; SE G2 |
|
| hCA - SCR G0; SE G3 |
|
| hCA - SCR G0; SE G4 |
|
| hCA - SCR G0; SE UNK |
|
| hCA - SCR G1; SE G0 |
|
| hCA - SCR G1; SE G1 |
|
| hCA - SCR G1; SE G2 |
|
| hCA - SCR G1; SE G3 |
|
| hCA - SCR G1; SE G4 |
|
| hCA - SCR G1; SE UNK |
|
| Title | Measurements |
|---|---|
|
| hKA - SCR UNK; SE G3 |
|
| hKA - SCR UNK; SE G4 |
|
| hKA - SCR UNK; SE UNK |
|
| hKA - SCR G0; SE G0 |
|
| hKA - SCR G0; SE G1 |
|
| hKA - SCR G0; SE G2 |
|
| hKA - SCR G0; SE G3 |
|
| hKA - SCR G0; SE G4 |
|
| hKA - SCR G0; SE UNK |
|
| Title | Measurements |
|---|---|
|
| hNA - SCR UNK; SE G3 |
|
| hNA - SCR UNK; SE G4 |
|
| hNA - SCR UNK; SE UNK |
|
| hNA - SCR G0; SE G0 |
|
| hNA - SCR G0; SE G1 |
|
| hNA - SCR G0; SE G2 |
|
| hNA - SCR G0; SE G3 |
|
| hNA - SCR G0; SE G4 |
|
| hNA - SCR G0; SE UNK |
|
| Title | Measurements |
|---|---|
|
| LEU - SCR G0; SE G3 |
|
| LEU - SCR G0; SE G4 |
|
| LEU - SCR G0; SE UNK |
|
| LEU - SCR G1; SE G0 |
|
| LEU - SCR G1; SE G1 |
|
| LEU - SCR G1; SE G2 |
|
| LEU - SCR G1; SE G3 |
|
| LEU - SCR G1; SE G4 |
|
| LEU - SCR G1; SE UNK |
|
| Title | Measurements |
|---|---|
|
| LYM - SCR G0; SE G3 |
|
| LYM - SCR G0; SE G4 |
|
| LYM - SCR G0; SE UNK |
|
| LYM - SCR G1; SE G0 |
|
| LYM - SCR G1; SE G1 |
|
| LYM - SCR G1; SE G2 |
|
| LYM - SCR G1; SE G3 |
|
| LYM - SCR G1; SE G4 |
|
| LYM - SCR G1; SE UNK |
|
| Title | Measurements |
|---|---|
|
| NEU - SCR G0; SE G3 |
|
| NEU - SCR G0; SE G4 |
|
| NEU - SCR G0; SE UNK |
|
| Title | Measurements |
|---|---|
|
| PLT - SCR G0; SE G3 |
|
| PLT - SCR G0; SE G4 |
|
| PLT - SCR G0; SE UNK |
|
| Title | Measurements |
|---|---|
|
| Patients with G3 AEs |
|
| Patients with G4 AEs |
|
| Patients with G5 AEs |
|
| Title | Measurements |
|---|---|
|
| Patients with G3 related AEs |
|
| Patients with G4 related AEs |
|
| Patients with G5 related AEs |
|
| Title | Measurements |
|---|---|
|
| Patients with G3 SAEs |
|
| Patients with G4 SAEs |
|
| Patients with G5 SAEs |
|
| Title | Measurements |
|---|---|
|
| Patients with G3 related SAEs |
|
| Patients with G4 related SAEs |
|
| Patients with G5 related SAEs |
|