| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001283-73 | EudraCT Number |
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The study was terminated following assessment of the lack of efficacy of the study product by the Independent Data monitoring Committee for the study.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK1572932 Group | Experimental | Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks. |
|
| Placebo Group | Placebo Comparator | Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK1572932A Antigen-Specific Cancer Immunotherapeutic | Biological | Intramuscular administration, 13 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
| 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
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.
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
Exclusion criteria
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.
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.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35294-3300 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27132212 | Background | Vansteenkiste JF, Cho BC, Vanakesa T, De Pas T, Zielinski M, Kim MS, Jassem J, Yoshimura M, Dahabreh J, Nakayama H, Havel L, Kondo H, Mitsudomi T, Zarogoulidis K, Gladkov OA, Udud K, Tada H, Hoffman H, Bugge A, Taylor P, Gonzalez EE, Liao ML, He J, Pujol JL, Louahed J, Debois M, Brichard V, Debruyne C, Therasse P, Altorki N. Efficacy of the MAGE-A3 cancer immunotherapeutic as adjuvant therapy in patients with resected MAGE-A3-positive non-small-cell lung cancer (MAGRIT): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2016 Jun;17(6):822-835. doi: 10.1016/S1470-2045(16)00099-1. Epub 2016 Apr 27. | |
| 31732522 |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 109493 | Individual Participant Data Set | View IPD |
IPD for this study is available via the Clinical Study Data Request site.
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.
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).
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK1572932 Group | Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks. |
| FG001 | Placebo Group | Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo Control | Biological | Intramuscular administration, 13 doses |
|
| 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| 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. | 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) |
| 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). | 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) |
| 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. | 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) |
| 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). | 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) |
| 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. | 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) |
| 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). | 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 |
| 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. | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) |
| 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. | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) |
| 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. | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) |
| 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. | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) |
| 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. | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) |
| 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. | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) |
| 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. | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) |
| 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. | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) |
| 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. | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) |
| 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. | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) |
| 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. | 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) |
| 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. | From screening (SCR) up to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) |
| Mobile |
| Alabama |
| 36604 |
| United States |
| GSK Investigational Site | Mobile | Alabama | 36608 | United States |
| GSK Investigational Site | Phoenix | Arizona | 85013 | United States |
| GSK Investigational Site | Scottsdale | Arizona | 85258 | United States |
| GSK Investigational Site | Scottsdale | Arizona | 85259 | United States |
| GSK Investigational Site | Tucson | Arizona | 85724 | United States |
| GSK Investigational Site | Fayetteville | Arkansas | 72703 | United States |
| GSK Investigational Site | Fort Smith | Arkansas | 72917 | United States |
| GSK Investigational Site | Jonesboro | Arkansas | 72401 | United States |
| GSK Investigational Site | Bakersfield | California | 93309 | United States |
| GSK Investigational Site | Beverly Hills | California | 90211 | United States |
| GSK Investigational Site | Burbank | California | 91505 | United States |
| GSK Investigational Site | Duarte | California | 91010 | United States |
| GSK Investigational Site | Fresno | California | 93720 | United States |
| GSK Investigational Site | Greenbrae | California | 94904-2007 | United States |
| GSK Investigational Site | La Jolla | California | 92093-0987 | United States |
| GSK Investigational Site | La Jolla | California | 92093 | United States |
| GSK Investigational Site | Los Angeles | California | 90095 | United States |
| GSK Investigational Site | Montebello | California | 90640 | United States |
| GSK Investigational Site | Orange | California | 92868 | United States |
| GSK Investigational Site | Palm Springs | California | 92262 | United States |
| GSK Investigational Site | Palo Alto | California | 94304 | United States |
| GSK Investigational Site | Pleasant Hill | California | 94523 | United States |
| GSK Investigational Site | Rancho Mirage | California | 92270 | United States |
| GSK Investigational Site | Sacramento | California | 95816 | United States |
| GSK Investigational Site | Sacramento | California | 95817 | United States |
| GSK Investigational Site | San Diego | California | 92121 | United States |
| GSK Investigational Site | San Diego | California | 92123 | United States |
| GSK Investigational Site | San Francisco | California | 94107 | United States |
| GSK Investigational Site | Santa Rosa | California | 95403-1757 | United States |
| GSK Investigational Site | Stanford | California | 94305 | United States |
| GSK Investigational Site | Vallejo | California | 94589 | United States |
| GSK Investigational Site | West Hollywood | California | 90048 | United States |
| GSK Investigational Site | Aurora | Colorado | 80045 | United States |
| GSK Investigational Site | Colorado Springs | Colorado | 80907 | United States |
| GSK Investigational Site | Danbury | Connecticut | 06810 | United States |
| GSK Investigational Site | Torrington | Connecticut | 06790 | United States |
| GSK Investigational Site | Waterbury | Connecticut | 06708 | United States |
| GSK Investigational Site | Newark | Delaware | 19713 | United States |
| GSK Investigational Site | Washington D.C. | District of Columbia | 20007 | United States |
| GSK Investigational Site | Boca Raton | Florida | 33486 | United States |
| GSK Investigational Site | Boynton Beach | Florida | 33435 | United States |
| GSK Investigational Site | Deerfield Beach | Florida | 33064 | United States |
| GSK Investigational Site | Fort Lauderdale | Florida | 33316 | United States |
| GSK Investigational Site | Hollywood | Florida | 33021 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32209 | United States |
| GSK Investigational Site | Ocala | Florida | 34474 | United States |
| GSK Investigational Site | Orlando | Florida | 32804 | United States |
| GSK Investigational Site | Orlando | Florida | 32806 | United States |
| GSK Investigational Site | Stuart | Florida | 34994 | United States |
| GSK Investigational Site | Tampa | Florida | 33606 | United States |
| GSK Investigational Site | West Palm Beach | Florida | 33401 | United States |
| GSK Investigational Site | Alpharetta | Georgia | 30005 | United States |
| GSK Investigational Site | Athens | Georgia | 30607 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30318 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30322 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30342 | United States |
| GSK Investigational Site | Augusta | Georgia | 30901 | United States |
| GSK Investigational Site | Macon | Georgia | 31201 | United States |
| GSK Investigational Site | Marietta | Georgia | 30060 | United States |
| GSK Investigational Site | Savannah | Georgia | 31405 | United States |
| GSK Investigational Site | Honolulu | Hawaii | 96813 | United States |
| GSK Investigational Site | Coeur d'Alene | Idaho | 83814 | United States |
| GSK Investigational Site | Chicago | Illinois | 60611 | United States |
| GSK Investigational Site | Chicago | Illinois | 60612 | United States |
| GSK Investigational Site | Chicago | Illinois | 60637 | United States |
| GSK Investigational Site | Decatur | Illinois | 62526 | United States |
| GSK Investigational Site | Evanston | Illinois | 60201 | United States |
| GSK Investigational Site | Harvey | Illinois | 60426 | United States |
| GSK Investigational Site | Park Ridge | Illinois | 60068 | United States |
| GSK Investigational Site | Peoria | Illinois | 61615-7822 | United States |
| GSK Investigational Site | Springfield | Illinois | 62794-9638 | United States |
| GSK Investigational Site | Evansville | Indiana | 47713 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46260 | United States |
| GSK Investigational Site | Indianapolis | Indiana | United States |
| GSK Investigational Site | Munster | Indiana | 46321 | United States |
| GSK Investigational Site | New Albany | Indiana | 47150 | United States |
| GSK Investigational Site | Waterloo | Iowa | 50701 | United States |
| GSK Investigational Site | Ashland | Kentucky | 41101 | United States |
| GSK Investigational Site | Hazard | Kentucky | 41701 | United States |
| GSK Investigational Site | Lexington | Kentucky | 40503 | United States |
| GSK Investigational Site | Louisville | Kentucky | 40245 | United States |
| GSK Investigational Site | Owensboro | Kentucky | 42303 | United States |
| GSK Investigational Site | Alexandria | Louisiana | 71301 | United States |
| GSK Investigational Site | Metairie | Louisiana | 70006 | United States |
| GSK Investigational Site | Shreveport | Louisiana | 71101 | United States |
| GSK Investigational Site | Annapolis | Maryland | 21401 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21201 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21204 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21215 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21237 | United States |
| GSK Investigational Site | Bethesda | Maryland | 20892-1201 | United States |
| GSK Investigational Site | Silver Spring | Maryland | 20902 | United States |
| GSK Investigational Site | Towson | Maryland | 21204 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02111 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02114 | United States |
| GSK Investigational Site | Boston | Massachusetts | 02118 | United States |
| GSK Investigational Site | Worcester | Massachusetts | 01605 | United States |
| GSK Investigational Site | Worcester | Massachusetts | 01608 | United States |
| GSK Investigational Site | Ann Arbor | Michigan | 48109 | United States |
| GSK Investigational Site | Bay City | Michigan | 48706 | United States |
| GSK Investigational Site | Detroit | Michigan | 48201 | United States |
| GSK Investigational Site | Detroit | Michigan | 48202 | United States |
| GSK Investigational Site | Flint | Michigan | 48503 | United States |
| GSK Investigational Site | Grand Rapids | Michigan | 49503 | United States |
| GSK Investigational Site | Lansing | Michigan | 48910 | United States |
| GSK Investigational Site | Lapeer | Michigan | 48446 | United States |
| GSK Investigational Site | Southfield | Michigan | 48075 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55407-3799 | United States |
| GSK Investigational Site | Minneapolis | Minnesota | 55455 | United States |
| GSK Investigational Site | Rochester | Minnesota | 55905 | United States |
| GSK Investigational Site | Saint Louis Park | Minnesota | 55416 | United States |
| GSK Investigational Site | Saint Louis Park | Minnesota | 55426 | United States |
| GSK Investigational Site | Kansas City | Missouri | 64111 | United States |
| GSK Investigational Site | Kansas City | Missouri | 64132 | United States |
| GSK Investigational Site | Springfield | Missouri | 65804 | United States |
| GSK Investigational Site | St Louis | Missouri | 63110 | United States |
| GSK Investigational Site | Billings | Montana | 59102 | United States |
| GSK Investigational Site | Grand Island | Nebraska | 68803 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68114 | United States |
| GSK Investigational Site | Henderson | Nevada | 89052 | United States |
| GSK Investigational Site | Lebanon | New Hampshire | 03756 | United States |
| GSK Investigational Site | Long Branch | New Jersey | 07740 | United States |
| GSK Investigational Site | Paramus | New Jersey | 07652 | United States |
| GSK Investigational Site | Armonk | New York | 10504 | United States |
| GSK Investigational Site | Buffalo | New York | 14263 | United States |
| GSK Investigational Site | East Syracuse | New York | 13057 | United States |
| GSK Investigational Site | Flushing | New York | 11355 | United States |
| GSK Investigational Site | Mineola | New York | 11501 | United States |
| GSK Investigational Site | New York | New York | 10003 | United States |
| GSK Investigational Site | New York | New York | 10011 | United States |
| GSK Investigational Site | New York | New York | 10016 | United States |
| GSK Investigational Site | New York | New York | 10019 | United States |
| GSK Investigational Site | New York | New York | 10032 | United States |
| GSK Investigational Site | New York | New York | 10065 | United States |
| GSK Investigational Site | Syracuse | New York | 13210 | United States |
| GSK Investigational Site | Chapel Hill | North Carolina | 27599-7065 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28203 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28204 | United States |
| GSK Investigational Site | Durham | North Carolina | 27705 | United States |
| GSK Investigational Site | Durham | North Carolina | 27710 | United States |
| GSK Investigational Site | Greenville | North Carolina | 27834 | United States |
| GSK Investigational Site | Akron | Ohio | 44304 | United States |
| GSK Investigational Site | Canton | Ohio | 44710 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45242 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45267 | United States |
| GSK Investigational Site | Columbus | Ohio | 43210 | United States |
| GSK Investigational Site | Dayton | Ohio | 45429 | United States |
| GSK Investigational Site | Tulsa | Oklahoma | 74136 | United States |
| GSK Investigational Site | Bend | Oregon | 97701 | United States |
| GSK Investigational Site | Portland | Oregon | 97213 | United States |
| GSK Investigational Site | Bethlehem | Pennsylvania | 18015 | United States |
| GSK Investigational Site | Danville | Pennsylvania | 17822 | United States |
| GSK Investigational Site | Lancaster | Pennsylvania | 17605 | United States |
| GSK Investigational Site | Langhorne | Pennsylvania | 19047 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19111 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19140 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15212 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15232 | United States |
| GSK Investigational Site | Sayre | Pennsylvania | 18840 | United States |
| GSK Investigational Site | Wilkes-Barre | Pennsylvania | 18702 | United States |
| GSK Investigational Site | Willow Grove | Pennsylvania | 19090 | United States |
| GSK Investigational Site | Providence | Rhode Island | 02903 | United States |
| GSK Investigational Site | Providence | Rhode Island | 02906 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29414 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29425 | United States |
| GSK Investigational Site | Columbia | South Carolina | 29209 | United States |
| GSK Investigational Site | Greenville | South Carolina | 29615 | United States |
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | United States |
| GSK Investigational Site | Sumter | South Carolina | 29150 | United States |
| GSK Investigational Site | Chattanooga | Tennessee | 37421 | United States |
| GSK Investigational Site | Cookeville | Tennessee | 38501 | United States |
| GSK Investigational Site | Knoxville | Tennessee | 37905 | United States |
| GSK Investigational Site | Knoxville | Tennessee | 37920 | United States |
| GSK Investigational Site | Memphis | Tennessee | 38104 | United States |
| GSK Investigational Site | Memphis | Tennessee | 38120 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37203 | United States |
| GSK Investigational Site | Amarillo | Texas | 79106 | United States |
| GSK Investigational Site | Dallas | Texas | 75230 | United States |
| GSK Investigational Site | Dallas | Texas | 75231 | United States |
| GSK Investigational Site | Dallas | Texas | 75246 | United States |
| GSK Investigational Site | Grapevine | Texas | 76051 | United States |
| GSK Investigational Site | Houston | Texas | 77030 | United States |
| GSK Investigational Site | Houston | Texas | 77090 | United States |
| GSK Investigational Site | Round Rock | Texas | 78665 | United States |
| GSK Investigational Site | Tyler | Texas | 75708-3154 | United States |
| GSK Investigational Site | Ogden | Utah | 84403 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84106 | United States |
| GSK Investigational Site | Fairfax | Virginia | 22031 | United States |
| GSK Investigational Site | Roanoke | Virginia | 24014 | United States |
| GSK Investigational Site | Everett | Washington | 98201 | United States |
| GSK Investigational Site | Seattle | Washington | 98104 | United States |
| GSK Investigational Site | Seattle | Washington | 98108 | United States |
| GSK Investigational Site | Seattle | Washington | 98109 | United States |
| GSK Investigational Site | Spokane | Washington | 99208 | United States |
| GSK Investigational Site | Tacoma | Washington | 98405 | United States |
| GSK Investigational Site | Vancouver | Washington | 98664 | United States |
| GSK Investigational Site | Madison | Wisconsin | 53792 | United States |
| GSK Investigational Site | Milwaukee | Wisconsin | 53226 | United States |
| GSK Investigational Site | C.a.b.a. | Buenos Aires | C1425EHD | Argentina |
| GSK Investigational Site | Ciudad Autonoma de Buenos Aires | Buenos Aires | C1430CLD | Argentina |
| GSK Investigational Site | Ciudad Autónoma de Buenos Aires | Buenos Aires | C1125ABD | Argentina |
| GSK Investigational Site | Córdoba | Córdoba Province | X5000JFK | Argentina |
| GSK Investigational Site | Cipolletti | Río Negro Province | R8324EMB | Argentina |
| GSK Investigational Site | Rosario | Santa Fe Province | S2000KZE | Argentina |
| GSK Investigational Site | Quilmes | 1878 | Argentina |
| GSK Investigational Site | San Miguel de Tucumán | 4000 | Argentina |
| GSK Investigational Site | Santa Fe | 3000 | Argentina |
| GSK Investigational Site | Garran | Australian Capital Territory | 2606 | Australia |
| GSK Investigational Site | Camperdown | New South Wales | 2050 | Australia |
| GSK Investigational Site | Tweed Heads | New South Wales | 2485 | Australia |
| GSK Investigational Site | Waratah | New South Wales | 2298 | Australia |
| GSK Investigational Site | Westmead | New South Wales | 2145 | Australia |
| GSK Investigational Site | Chermside | Queensland | 4032 | Australia |
| GSK Investigational Site | South Brisbane | Queensland | 4101 | Australia |
| GSK Investigational Site | Woolloongabba | Queensland | 4102 | Australia |
| GSK Investigational Site | Adelaide | South Australia | 5000 | Australia |
| GSK Investigational Site | Hobart | Tasmania | 7000 | Australia |
| GSK Investigational Site | Box Hill | Victoria | 3128 | Australia |
| GSK Investigational Site | Fitzroy | Victoria | 3065 | Australia |
| GSK Investigational Site | Heidelberg | Victoria | 3084 | Australia |
| GSK Investigational Site | Richmond | Victoria | 3121 | Australia |
| GSK Investigational Site | Nedlands | Western Australia | 6009 | Australia |
| GSK Investigational Site | Perth | Western Australia | 6001 | Australia |
| GSK Investigational Site | Graz | A-8036 | Austria |
| GSK Investigational Site | Innsbruck | 6020 | Austria |
| GSK Investigational Site | Linz | A-4010 | Austria |
| GSK Investigational Site | Linz | A-4020 | Austria |
| GSK Investigational Site | Salzburg | A-5020 | Austria |
| GSK Investigational Site | Vienna | 1130 | Austria |
| GSK Investigational Site | Vienna | A-1090 | Austria |
| GSK Investigational Site | Wels | A-4600 | Austria |
| GSK Investigational Site | Antwerp | 2020 | Belgium |
| GSK Investigational Site | Brussels | 1070 | Belgium |
| GSK Investigational Site | Brussels | 1200 | Belgium |
| GSK Investigational Site | Charleroi | 6000 | Belgium |
| GSK Investigational Site | Duffel | 2570 | Belgium |
| GSK Investigational Site | Edegem | 2650 | Belgium |
| GSK Investigational Site | Genk | 3600 | Belgium |
| GSK Investigational Site | Hasselt | 3500 | Belgium |
| GSK Investigational Site | Jette | 1090 | Belgium |
| GSK Investigational Site | Leuven | 3000 | Belgium |
| GSK Investigational Site | Liège | 4000 | Belgium |
| GSK Investigational Site | Namur | 5000 | Belgium |
| GSK Investigational Site | Belo Horizonte | Minas Gerais | 30730-540 | Brazil |
| GSK Investigational Site | Porto Alegre | Rio Grande do Sul | 90610 000 | Brazil |
| GSK Investigational Site | Barretos | São Paulo | 14784-400 | Brazil |
| GSK Investigational Site | Santo André | São Paulo | 09060-650 | Brazil |
| GSK Investigational Site | Rio de Janeiro | 20230-130 | Brazil |
| GSK Investigational Site | São Paulo | 01224-010 | Brazil |
| GSK Investigational Site | São Paulo | 01308-050 | Brazil |
| GSK Investigational Site | São Paulo | 01509-900 | Brazil |
| GSK Investigational Site | Calgary | Alberta | T2N 4N2 | Canada |
| GSK Investigational Site | Edmonton | Alberta | T6G 1Z2 | Canada |
| GSK Investigational Site | Surrey | British Columbia | V3V 1N1 | Canada |
| GSK Investigational Site | Halifax | Nova Scotia | B3J 2Y9 | Canada |
| GSK Investigational Site | Hamilton | Ontario | L8V 5C2 | Canada |
| GSK Investigational Site | London | Ontario | N6A 5W9 | Canada |
| GSK Investigational Site | Newmarket | Ontario | L3Y 2P9 | Canada |
| GSK Investigational Site | Saint Catherines | Ontario | L2S 0A9 | Canada |
| GSK Investigational Site | Scarborough Village | Ontario | M1P 2V5 | Canada |
| GSK Investigational Site | Toronto | Ontario | M4C 3E7 | Canada |
| GSK Investigational Site | Toronto | Ontario | M5G 1X5 | Canada |
| GSK Investigational Site | Toronto | Ontario | M6R 1B5 | Canada |
| GSK Investigational Site | Greenfield Park | Quebec | J4V 2H1 | Canada |
| GSK Investigational Site | Montreal | Quebec | H1T 2M4 | Canada |
| GSK Investigational Site | Montreal | Quebec | H2L 4M1 | Canada |
| GSK Investigational Site | Montreal | Quebec | H3T1E2 | Canada |
| GSK Investigational Site | Montreal | Quebec | H4J 1C5 | Canada |
| GSK Investigational Site | Québec | G1V 4G5 | Canada |
| GSK Investigational Site | Guangzhou | Guangdong | 510060 | China |
| GSK Investigational Site | Guangzhou | Guangdong | 510120 | China |
| GSK Investigational Site | Nanning | Guangxi | 530021 | China |
| GSK Investigational Site | Wuhan | Hubei | 430030 | China |
| GSK Investigational Site | Nanjing | Jiangsu | 210002 | China |
| GSK Investigational Site | Changchun | Jilin | 130012 | China |
| GSK Investigational Site | Chengdu | Sichuan | 610041 | China |
| GSK Investigational Site | Hangzhou | Zhejiang | 310003 | China |
| GSK Investigational Site | Hangzhou | Zhejiang | 310022 | China |
| GSK Investigational Site | Beijing | China |
| GSK Investigational Site | Changsha | China |
| GSK Investigational Site | Guangzhou | China |
| GSK Investigational Site | Harbin | China |
| GSK Investigational Site | Shanghai | 200030 | China |
| GSK Investigational Site | Shanghai | 200032 | China |
| GSK Investigational Site | Shanghai | 200433 | China |
| GSK Investigational Site | Tianjin | 300052 | China |
| GSK Investigational Site | Wuhan | China |
| GSK Investigational Site | Brno | 625 00 | Czechia |
| GSK Investigational Site | Ostrava | 708 52 | Czechia |
| GSK Investigational Site | Pilsen | 305 99 | Czechia |
| GSK Investigational Site | Prague | 150 06 | Czechia |
| GSK Investigational Site | Prague | 180 01 | Czechia |
| GSK Investigational Site | Ústí nad Labem | 401 12 | Czechia |
| GSK Investigational Site | Tallinn | 13419 | Estonia |
| GSK Investigational Site | Tartu | 51014 | Estonia |
| GSK Investigational Site | Helsinki | 00029 | Finland |
| GSK Investigational Site | Oulu | 90220 | Finland |
| GSK Investigational Site | Tampere | 33520 | Finland |
| GSK Investigational Site | Turku | 20520 | Finland |
| GSK Investigational Site | Angers | 49933 | France |
| GSK Investigational Site | Bayonne | 64100 | France |
| GSK Investigational Site | Beauvais | 60021 | France |
| GSK Investigational Site | Béthune | 62408 | France |
| GSK Investigational Site | Bordeaux | 33000 | France |
| GSK Investigational Site | Brest | 29609 | France |
| GSK Investigational Site | Bron | 69677 | France |
| GSK Investigational Site | Caen | 14033 | France |
| GSK Investigational Site | Elbeuf | 76503 | France |
| GSK Investigational Site | Lille | 59000 | France |
| GSK Investigational Site | Lille | 59037 | France |
| GSK Investigational Site | Limoges | 87042 | France |
| GSK Investigational Site | Lorient | 56322 | France |
| GSK Investigational Site | Lyon | 69003 | France |
| GSK Investigational Site | Lyon | 69365 | France |
| GSK Investigational Site | Lyon | 69373 | France |
| GSK Investigational Site | Marseille | 13915 | France |
| GSK Investigational Site | Meaux | 77104 | France |
| GSK Investigational Site | Metz | 57038 | France |
| GSK Investigational Site | Montpellier | 34295 | France |
| GSK Investigational Site | Mulhouse | 68070 | France |
| GSK Investigational Site | Nantes | 44202 | France |
| GSK Investigational Site | Nice | 06002 | France |
| GSK Investigational Site | Nîmes | 30029 | France |
| GSK Investigational Site | Paris | 75014 | France |
| GSK Investigational Site | Paris | 75018 | France |
| GSK Investigational Site | Paris | 75020 | France |
| GSK Investigational Site | Paris | 75248 | France |
| GSK Investigational Site | Paris | 75970 | France |
| GSK Investigational Site | Perpignan | 66000 | France |
| GSK Investigational Site | Périgueux | 24019 | France |
| GSK Investigational Site | Reims | 51100 | France |
| GSK Investigational Site | Rennes | 35033 | France |
| GSK Investigational Site | Rouen | 76000 | France |
| GSK Investigational Site | Saint-Grégoire | 35768 | France |
| GSK Investigational Site | Saint-Herblain | 44805 | France |
| GSK Investigational Site | Saint-Priest-en-Jarez | 42271 | France |
| GSK Investigational Site | Saint-Quentin | 02321 | France |
| GSK Investigational Site | Toulon | 83041 | France |
| GSK Investigational Site | Toulouse | 31059 | France |
| GSK Investigational Site | Vannes | 56017 | France |
| GSK Investigational Site | Villefranche-sur-Saône | 69655 | France |
| GSK Investigational Site | Freiburg im Breisgau | Baden-Wurttemberg | 79106 | Germany |
| GSK Investigational Site | Heidelberg | Baden-Wurttemberg | 69126 | Germany |
| GSK Investigational Site | Ulm | Baden-Wurttemberg | 89081 | Germany |
| GSK Investigational Site | Villingen-Schwenningen | Baden-Wurttemberg | 78050 | Germany |
| GSK Investigational Site | Wangen | Baden-Wurttemberg | 88239 | Germany |
| GSK Investigational Site | Augsburg | Bavaria | 86156 | Germany |
| GSK Investigational Site | Bayreuth | Bavaria | 95445 | Germany |
| GSK Investigational Site | Ebensfeld | Bavaria | 96250 | Germany |
| GSK Investigational Site | Gauting | Bavaria | 82131 | Germany |
| GSK Investigational Site | Munich | Bavaria | 81925 | Germany |
| GSK Investigational Site | Regensburg | Bavaria | 93049 | Germany |
| GSK Investigational Site | Regensburg | Bavaria | 93053 | Germany |
| GSK Investigational Site | Rosenheim | Bavaria | 83022 | Germany |
| GSK Investigational Site | Würzburg | Bavaria | 97070 | Germany |
| GSK Investigational Site | Frankfurt (Oder) | Brandenburg | 15236 | Germany |
| GSK Investigational Site | Darmstadt | Hesse | 64283 | Germany |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60487 | Germany |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60488 | Germany |
| GSK Investigational Site | Frankfurt am Main | Hesse | 60590 | Germany |
| GSK Investigational Site | Fulda | Hesse | 36043 | Germany |
| GSK Investigational Site | Immenhausen | Hesse | 34376 | Germany |
| GSK Investigational Site | Offenbach | Hesse | 63069 | Germany |
| GSK Investigational Site | Braunschweig | Lower Saxony | 38114 | Germany |
| GSK Investigational Site | Hanover | Lower Saxony | 30625 | Germany |
| GSK Investigational Site | Oldenburg | Lower Saxony | 26121 | Germany |
| GSK Investigational Site | Ostercappeln | Lower Saxony | 49179 | Germany |
| GSK Investigational Site | Greifswald | Mecklenburg-Vorpommern | 17487 | Germany |
| GSK Investigational Site | Rostock | Mecklenburg-Vorpommern | 18057 | Germany |
| GSK Investigational Site | Bielefeld | North Rhine-Westphalia | 33604 | Germany |
| GSK Investigational Site | Bielefeld | North Rhine-Westphalia | 33611 | Germany |
| GSK Investigational Site | Bochum | North Rhine-Westphalia | 44791 | Germany |
| GSK Investigational Site | Bonn | North Rhine-Westphalia | 53113 | Germany |
| GSK Investigational Site | Cologne | North Rhine-Westphalia | 50931 | Germany |
| GSK Investigational Site | Cologne | North Rhine-Westphalia | 51109 | Germany |
| GSK Investigational Site | Essen | North Rhine-Westphalia | 45122 | Germany |
| GSK Investigational Site | Essen | North Rhine-Westphalia | 45136 | Germany |
| GSK Investigational Site | Hemer | North Rhine-Westphalia | 58675 | Germany |
| GSK Investigational Site | Herne | North Rhine-Westphalia | 44623 | Germany |
| GSK Investigational Site | Lüdenscheid | North Rhine-Westphalia | 58515 | Germany |
| GSK Investigational Site | Moers | North Rhine-Westphalia | 47441 | Germany |
| GSK Investigational Site | Mülheim | North Rhine-Westphalia | 45473 | Germany |
| GSK Investigational Site | Münster | North Rhine-Westphalia | 48149 | Germany |
| GSK Investigational Site | Münster | North Rhine-Westphalia | 48153 | Germany |
| GSK Investigational Site | Neuss | North Rhine-Westphalia | 41464 | Germany |
| GSK Investigational Site | Oberhausen | North Rhine-Westphalia | 46145 | Germany |
| GSK Investigational Site | Porta Westfalica | North Rhine-Westphalia | 32457 | Germany |
| GSK Investigational Site | Troisdorf | North Rhine-Westphalia | 53840 | Germany |
| GSK Investigational Site | Velbert | North Rhine-Westphalia | 42551 | Germany |
| GSK Investigational Site | Waldbröl | North Rhine-Westphalia | 51545 | Germany |
| GSK Investigational Site | Koblenz | Rhineland-Palatinate | 56068 | Germany |
| GSK Investigational Site | Mainz | Rhineland-Palatinate | 55131 | Germany |
| GSK Investigational Site | Trier | Rhineland-Palatinate | 54290 | Germany |
| GSK Investigational Site | Homburg | Saarland | 66421 | Germany |
| GSK Investigational Site | Dresden | Saxony | 01307 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04103 | Germany |
| GSK Investigational Site | Leipzig | Saxony | 04129 | Germany |
| GSK Investigational Site | Zwickau | Saxony | 08058 | Germany |
| GSK Investigational Site | Halle | Saxony-Anhalt | 06114 | Germany |
| GSK Investigational Site | Halle | Saxony-Anhalt | 06120 | Germany |
| GSK Investigational Site | Weißenfels | Saxony-Anhalt | 06667 | Germany |
| GSK Investigational Site | Großhansdorf | Schleswig-Holstein | 22927 | Germany |
| GSK Investigational Site | Kiel | Schleswig-Holstein | 24105 | Germany |
| GSK Investigational Site | Lübeck | Schleswig-Holstein | 23538 | Germany |
| GSK Investigational Site | Bad Berka | Thuringia | 99437 | Germany |
| GSK Investigational Site | Berlin | 10117 | Germany |
| GSK Investigational Site | Berlin | 12200 | Germany |
| GSK Investigational Site | Berlin | 12351 | Germany |
| GSK Investigational Site | Berlin | 13125 | Germany |
| GSK Investigational Site | Berlin | 13353 | Germany |
| GSK Investigational Site | Bremen | 28325 | Germany |
| GSK Investigational Site | Hamburg | 20246 | Germany |
| GSK Investigational Site | Hamburg | 21075 | Germany |
| GSK Investigational Site | Athens | 10676 | Greece |
| GSK Investigational Site | Athens | 115 27 | Greece |
| GSK Investigational Site | Athens | 11526 | Greece |
| GSK Investigational Site | Athens | 11527 | Greece |
| GSK Investigational Site | Athens | 145 64 | Greece |
| GSK Investigational Site | Chania | 73100 | Greece |
| GSK Investigational Site | Heraklion | 71110 | Greece |
| GSK Investigational Site | Larissa | 411 10 | Greece |
| GSK Investigational Site | Marousi | 15125 | Greece |
| GSK Investigational Site | Neo Faliro | 18547 | Greece |
| GSK Investigational Site | Pátrai | 26500 | Greece |
| GSK Investigational Site | Piraeus | 18537 | Greece |
| GSK Investigational Site | Pylaia | 57001 | Greece |
| GSK Investigational Site | Thessaloniki | 540 07 | Greece |
| GSK Investigational Site | Thessaloniki | 57010 | Greece |
| GSK Investigational Site | Kowloon | Hong Kong |
| GSK Investigational Site | Shatin | Hong Kong |
| GSK Investigational Site | Budapest | 1529 | Hungary |
| GSK Investigational Site | Budapest | Hungary |
| GSK Investigational Site | Deszk | 6772 | Hungary |
| GSK Investigational Site | Győr | 9024 | Hungary |
| GSK Investigational Site | Gyula | 5703 | Hungary |
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| GSK Investigational Site | Saint Petersburg | 197758 | Russia |
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| GSK Investigational Site | Cambridge | Cambridgeshire | CB2 2RE | United Kingdom |
| GSK Investigational Site | Wythenshawe | Greater Manchester | M23 9LT | United Kingdom |
| GSK Investigational Site | Leicester | Leicestershire | LE1 5WW | United Kingdom |
| GSK Investigational Site | Edinburgh | Midlothian | EH4 2XU | United Kingdom |
| GSK Investigational Site | Sutton | Surrey | SM2 5PT | United Kingdom |
| GSK Investigational Site | Aberdeen | AB25 2ZN | United Kingdom |
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| GSK Investigational Site | Belfast | BT9 7AB | United Kingdom |
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| GSK Investigational Site | London | SW3 6JJ | United Kingdom |
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| Background |
| Dizier B, Callegaro A, Debois M, Dreno B, Hersey P, Gogas HJ, Kirkwood JM, Vansteenkiste JF, Sequist LV, Atanackovic D, Goeman J, van Houwelingen H, Salceda S, Wang F, Therasse P, Debruyne C, Spiessens B, Brichard VG, Louahed J, Ulloa-Montoya F. A Th1/IFNgamma Gene Signature Is Prognostic in the Adjuvant Setting of Resectable High-Risk Melanoma but Not in Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 Apr 1;26(7):1725-1735. doi: 10.1158/1078-0432.CCR-18-3717. Epub 2019 Nov 15. |
| 34870327 | Derived | Zhu J, Yuan Y, Wan X, Yin D, Li R, Chen W, Suo C, Song H. Immunotherapy (excluding checkpoint inhibitors) for stage I to III non-small cell lung cancer treated with surgery or radiotherapy with curative intent. Cochrane Database Syst Rev. 2021 Dec 6;12(12):CD011300. doi: 10.1002/14651858.CD011300.pub3. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 109493 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109493 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109493 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109493 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109493 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 109493 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GSK1572932 Group | Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks. |
| BG001 | Placebo Group | Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | Posted | Number | events/person-years | 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) |
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| 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. | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | Posted | Number | events/person-years | 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) |
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| 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. | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | Posted | Number | events/person-years | 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) |
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| 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. | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | Posted | Number | events/person-years | 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) |
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| 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. | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | Posted | Number | events/person-years | 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) |
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| 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. | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | Posted | Number | events/person-years | 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) |
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| 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. | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | Posted | Number | events/person-years | 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) |
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| 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. | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | Posted | Number | events/person-years | 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) |
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| 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. | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | Posted | Number | events/person-years | 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) |
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| 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. | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | Posted | Median | 95% Confidence Interval | percent probability | 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) |
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| 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. | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | Posted | Median | 95% Confidence Interval | percent probability | 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) |
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| 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. | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | Posted | Median | 95% Confidence Interval | percent probability | 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) |
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| 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. | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | Posted | Number | events/person-years | 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) |
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| 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. | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | Posted | Number | events/person-years | 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) |
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| 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. | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | Posted | Number | events/person-years | 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) |
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| 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). | 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. | Posted | Count of Participants | Participants | 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) |
|
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| 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. | 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. | Posted | Count of Participants | Participants | 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) |
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| 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). | 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. | Posted | Count of Participants | Participants | 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) |
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| 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. | 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. | Posted | Count of Participants | Participants | 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) |
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| 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). | The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study. | Posted | Mean | Standard Deviation | Scores on a scale | 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 |
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| 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. | The Total Treated population - as treated included patients in the treatment group as per treatment actually received. | Posted | Count of Participants | Participants | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) |
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| 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. | The Total Treated population - as treated included patients in the treatment group as per treatment actually received. | Posted | Count of Participants | Participants | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) |
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| 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. | The Total Treated population - as treated included patients in the treatment group as per treatment actually received. | Posted | Count of Participants | Participants | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) |
|
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| 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. | The Total Treated population - as treated included patients in the treatment group as per treatment actually received. | Posted | Count of Participants | Participants | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) |
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| 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. | The Total Treated population - as treated included patients in the treatment group as per treatment actually received. | Posted | Count of Participants | Participants | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) |
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| 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. | The Total Treated population - as treated included patients in the treatment group as per treatment actually received. | Posted | Count of Participants | Participants | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) |
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| 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. | The Total Treated population - as treated included patients in the treatment group as per treatment actually received. | Posted | Count of Participants | Participants | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) |
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| 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. | The Total Treated population - as treated included patients in the treatment group as per treatment actually received. | Posted | Count of Participants | Participants | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) |
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| 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. | The Total Treated population - as treated included patients in the treatment group as per treatment actually received. | Posted | Count of Participants | Participants | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) |
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| 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. | The Total Treated population - as treated included patients in the treatment group as per treatment actually received. | Posted | Count of Participants | Participants | From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) |
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| 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. | The Total Treated population - as treated included patients in the treatment group as per treatment actually received. | Posted | Count of Participants | Participants | 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) |
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| 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. | The Total Treated population - as treated included patients in the treatment group as per treatment actually received. | Posted | Count of Participants | Participants | From screening (SCR) up to data lock point (DLP) on 23 January 2014 (up to 5 years per patient) |
|
From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
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 | GSK1572932 Group | Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks. | 30 | 1,515 | 330 | 1,515 | 1,225 | 1,515 |
| EG001 | Placebo Group | Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks. | 17 | 757 | 164 | 757 | 300 | 757 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aortic aneurysm | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Aortic aneurysm rupture | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bleeding varicose vein | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
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| Circulatory collapse | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Neurogenic shock | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pelvic venous thrombosis | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Peripheral embolism | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Peripheral vascular disorder | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Superior vena cava syndrome | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Adenocarcinoma gastric | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Adenocarcinoma pancreas | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Benign oesophageal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Bladder transitional cell carcinoma stage ii | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Brenner tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Carcinoma in situ of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Cerebral haemangioma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Cholangiocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Clear cell renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Dermatofibrosarcoma protuberans | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Diffuse large b-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Gastrointestinal stromal tumour | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Hepatic cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Intraductal proliferative breast lesion | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Laryngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Laryngeal squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Lentigo maligna | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Malignant peritoneal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Metastases to central nervous system | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Oropharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Ovarian cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Ovarian fibroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Prostate cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Rectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Seborrhoeic keratosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of pharynx | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Tracheal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Squamous cell carcinoma of skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 16.1 | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Immune system disorder | Immune system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Euthanasia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Impaired healing | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Mass | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Multi-organ failure | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Sudden death | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Completed suicide | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Acquired hydrocele | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bronchostenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Accidental overdose | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Clavicle fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Multiple fractures | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Multiple injuries | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Post procedural haematoma | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Post procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Postoperative thoracic procedure complication | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Procedural haemorrhage | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Procedural intestinal perforation | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Splenic rupture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Toxicity to various agents | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Vascular pseudoaneurysm | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Blood uric acid increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 16.1 | Systematic Assessment |
| |
| Acute coronary syndrome | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Adams-stokes syndrome | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Atrial tachycardia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Atrioventricular block | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bradyarrhythmia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiac fibrillation | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiac flutter | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cardiomyopathy | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Congestive cardiomyopathy | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Coronary artery occlusion | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypertensive heart disease | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Left ventricular dysfunction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Prinzmetal angina | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Silent myocardial infarction | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Stress cardiomyopathy | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Alveolitis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Apnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bronchopleural fistula | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumothorax spontaneous | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pulmonary artery thrombosis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pulmonary granuloma | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pulmonary mass | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Anaemia macrocytic | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypersplenism | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Transient global amnesia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Unresponsive to stimuli | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Age-related macular degeneration | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Macular fibrosis | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Retinal artery occlusion | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal hernia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Colitis microscopic | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diaphragmatic hernia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diverticular perforation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diverticulitis intestinal haemorrhagic | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diverticulum intestinal | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Duodenal obstruction | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Duodenal stenosis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Duodenal ulcer haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gastric haemorrhage | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gastric polyps | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Inguinal hernia, obstructive | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Intestinal polyp | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Melaena | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Oesophagitis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Oesophagitis ulcerative | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pancreatic necrosis | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pancreatitis chronic | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Peritoneal adhesions | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Glomerulonephritis rapidly progressive | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Renal failure acute | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ureteric dilatation | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Urethral stenosis | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Urinary bladder polyp | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cholangitis acute | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cholangitis chronic | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Portal vein thrombosis | Hepatobiliary disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Leukocytoclastic vasculitis | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Spinal column stenosis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Systemic sclerosis | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Autoimmune thyroiditis | Endocrine disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Insulin-requiring type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Metabolic alkalosis | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Metabolic disorder | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Abscess | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Acute hepatitis b | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Carbuncle | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Cellulitis streptococcal | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Chest wall abscess | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Citrobacter infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Diarrhoea infectious | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Gastroenteritis clostridial | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Hepatitis b | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Infectious pleural effusion | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Infective exacerbation of chronic obstructive airways diseas | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Lower respiratory tract infection viral | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia haemophilus | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia pseudomonas aeruginosa | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pneumonia staphylococcal | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Post procedural infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Q fever | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Renal abscess | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Rickettsiosis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Streptococcal bacteraemia | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Urinary tract infection bacterial | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Vestibular neuronitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Viral pericarditis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
| |
| Hypochromic anaemia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Idiopathic thrombocytopenic purpura | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Lymphocytosis | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Brain injury | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cerebral ischaemia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dementia Alzheimer's type | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Intracranial aneurysm | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Injection site reaction | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 16.1 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| Male |
|
| American Indian or Alaskan Native |
|
| Asian - Central/South Asian heritage |
|
| Asian - East Asian heritage |
|
| Asian - Japanese heritage |
|
| Asian - South East Asian heritage |
|
| Native Hawaiian or other Pacific Islander |
|
| White - Arabic//North African heritage |
|
| White - Caucasian/European heritage |
|
| Other |
|
| Missing confirmed |
|
| Superiority |
RMF included: 1) Number of chemotherapy cycles received (1, 2 vs. 3, 4), if any; 2) Pathological stage of the disease (IB vs. II vs. IIIA); 3) Type of lymph-node sampling (minimal lymph-node sampling vs. systematic radical mediastinal lymphadenectomy); 4) ECOG performance status randomization (0, 1 vs. 2); 5) Smoking status ( 100 cigarettes a lifetime vs. > 100 cigarettes and current smoker vs. >100 cigarettes and past smoker). |
| OG001 | Placebo No-CT Group | Patients received up to 13 doses (D) of placebo, 5 Ds every 3 weeks followed by 8 Ds every 12 weeks. Patients in this sub-group consisted solely of patients who had not received adjuvant chemotherapy prior to randomization (No-CT Population). |
|
|
|
| OG001 | Placebo CT Group | Patients received up to 13 doses (D) of placebo, 5 Ds every 3 weeks followed by 8 Ds every 12 weeks. Patients in this sub-group consisted solely of patients who had received adjuvant chemotherapy prior to randomization (CT Population). |
|
|
| Participants |
|
|
|
|
|
|
| Participants |
|
|
|
|
|
|
| OG001 | Placebo Group | Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks. |
|
|
| OG001 | Placebo No-CT Group | Patients received up to 13 doses (D) of placebo, 5 Ds every 3 weeks followed by 8 Ds every 12 weeks. Patients in this sub-group consisted solely of patients who had not received adjuvant chemotherapy prior to randomization (No-CT Population). |
|
|
| OG001 | Placebo CT Group | Patients received up to 13 doses (D) of placebo, 5 Ds every 3 weeks followed by 8 Ds every 12 weeks. Patients in this sub-group consisted solely of patients who had received adjuvant chemotherapy prior to randomization (CT Population). |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
|
|
|
| Participants |
|
|
|
|
| Participants |
|
|
|
|
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|