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GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT00480025
Recruitment Status : Terminated (The study was terminated following assessment of the lack of efficacy of the study product by the Independent Data monitoring Committee for the study.)
First Posted : May 30, 2007
Results First Posted : January 30, 2019
Last Update Posted : December 22, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Lung Cancer, Non-Small Cell
Interventions Biological: GSK1572932A Antigen-Specific Cancer Immunotherapeutic
Biological: Placebo Control
Enrollment 2278
Recruitment Details A total of 2315 patients were screened towards participation in the study. For 3 of these subjects informed consent forms issues were reported, and thus only 2312 subjects were considered for analyses/results Out of these 2312 subjects, 2278 were enrolled in the study.
Pre-assignment Details Out of the 2278 patients initially enrolled into the study, only 2272 patients received at least one dose of study treatment (1515 received GSK1572932 and 757 received placebo).
Arm/Group Title GSK1572932 Group Placebo Group
Hide Arm/Group Description Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks. Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Period Title: Overall Study
Started 1515 757
Completed 763 388
Not Completed 752 369
Reason Not Completed
Protocol Violation             12             7
Patients remaining ongoing at Data Lock             101             55
Disease Progression / Recurrence             449             224
Adverse Event             44             12
Other             70             29
SAE including intercurrent illness             76             42
Arm/Group Title GSK1572932 Group Placebo Group Total
Hide Arm/Group Description Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks. Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks. Total of all reporting groups
Overall Number of Baseline Participants 1515 757 2272
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1515 participants 757 participants 2272 participants
63.1  (8.96) 63.4  (9.15) 63.2  (9.02)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1515 participants 757 participants 2272 participants
Female
370
  24.4%
179
  23.6%
549
  24.2%
Male
1145
  75.6%
578
  76.4%
1723
  75.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Geographic ancestry Number Analyzed 1515 participants 757 participants 2272 participants
African heritage/African American
14
   0.9%
7
   0.9%
21
   0.9%
American Indian or Alaskan Native
0
   0.0%
1
   0.1%
1
   0.0%
Asian - Central/South Asian heritage
8
   0.5%
5
   0.7%
13
   0.6%
Asian - East Asian heritage
195
  12.9%
112
  14.8%
307
  13.5%
Asian - Japanese heritage
138
   9.1%
71
   9.4%
209
   9.2%
Asian - South East Asian heritage
13
   0.9%
10
   1.3%
23
   1.0%
Native Hawaiian or other Pacific Islander
0
   0.0%
1
   0.1%
1
   0.0%
White - Arabic//North African heritage
7
   0.5%
9
   1.2%
16
   0.7%
White - Caucasian/European heritage
1129
  74.5%
539
  71.2%
1668
  73.4%
Other
11
   0.7%
1
   0.1%
12
   0.5%
Missing confirmed
0
   0.0%
1
   0.1%
1
   0.0%
1.Primary Outcome
Title Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the Overall Population
Hide Description DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence [any tumor arising in contralateral lung or outside hemithorax]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. PYAR= n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.
Time Frame From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
Arm/Group Title GSK1572932 Group Placebo Group
Hide Arm/Group Description:
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Overall Number of Participants Analyzed 1515 757
Measure Type: Number
Unit of Measure: events/person-years
0.17 0.168
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK1572932 Group, Placebo Group
Comments Analysis compared DFS PYAR between groups for period from 1st treatment dose to DLP. A Cox model was used to evaluate treatment efficacy (TE). TE was calculated as PYAR in GSK1572932 Group (PYAR1) divided by PYAR in Placebo Group (PYAR2), and weighed for adjustment factors. This comparison in all patients (overall population) also included taking into account stratification by previous CT vs. No-CT treatment and weighing using randomization-minimization factors (RMF) as regressors.
Type of Statistical Test Superiority
Comments 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).
Statistical Test of Hypothesis P-Value 0.7379
Comments 2-sided p-value of Likelihood Ratio test from RMF-adjusted Cox regression, Efron method used to handle ties.
Method Regression, Cox
Comments Overall population objective reached if p-value < 2.56%/4% in absence/presence of statistically significant effect in the No-CT population.
Method of Estimation Estimation Parameter Treatment Efficacy
Estimated Value 1.024
Confidence Interval (2-Sided) 95%
0.891 to 1.177
Estimation Comments [Not Specified]
2.Primary Outcome
Title Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the No-CT Population
Hide Description DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence [any tumor arising in contralateral lung or outside hemithorax]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. PYAR= n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.
Time Frame From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
Arm/Group Title GSK1572932 No-CT Group Placebo No-CT Group
Hide Arm/Group Description:
Patients received up to 13 doses (D) of GSK1572932 ASCI, 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).
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).
Overall Number of Participants Analyzed 731 365
Measure Type: Number
Unit of Measure: events/person-years
0.169 0.178
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection GSK1572932 No-CT Group, Placebo No-CT Group
Comments Analysis compared DFS PYAR between groups for the period from 1st treatment dose to DLP. A Cox model was used to evaluate treatment efficacy (TE). TE was calculated as PYAR in GSK1572932 No-CT Group (PYAR1) divided by PYAR in Placebo No-CT Group (PYAR2) and weighed for adjustment factors. This comparison in all patients (overall population) also included taking into account weighing using randomization-minimization factors (RMF) as regressors.
Type of Statistical Test Superiority
Comments RMF taken into account 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).
Statistical Test of Hypothesis P-Value 0.7572
Comments 2-sided p-value of Likelihood Ratio test from RMF-adjusted Cox regression, Efron method used to handle ties.
Method Regression, Cox
Comments No-CT population objective reached if p-value < 2.56%/4% in absence/presence of statistically significant effect in the No-CT population.
Method of Estimation Estimation Parameter Treatment Efficacy
Estimated Value 0.97
Confidence Interval (2-Sided) 95%
0.797 to 1.179
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the CT Population
Hide Description DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence [any tumor arising in contralateral lung or outside hemithorax]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.
Time Frame From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
Arm/Group Title GSK1572932 CT Group Placebo CT Group
Hide Arm/Group Description:
Patients received up to 13 doses (D) of GSK1572932, 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).
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).
Overall Number of Participants Analyzed 784 392
Measure Type: Number
Unit of Measure: events/person-years
0.172 0.158
4.Secondary Outcome
Title Person Year Rate (PYAR) as Regards Overall-survival (OS) in the Overall Population
Hide Description OS was defined as the time interval from randomization to the date of death, irrespective of the cause of death. Patients still alive were censored at the last visit they were known to be alive. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.
Time Frame From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
Arm/Group Title GSK1572932 Group Placebo Group
Hide Arm/Group Description:
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Overall Number of Participants Analyzed 1515 757
Measure Type: Number
Unit of Measure: events/person-years
0.082 0.081
5.Secondary Outcome
Title Person Year Rate (PYAR) as Regards Overall-survival (OS) in the No-CT Population
Hide Description OS was defined as the time interval from randomization to the date of death, irrespective of the cause of death. Patients still alive were censored at the last visit they were known to be alive. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.
Time Frame From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
Arm/Group Title GSK1572932 No-CT Group Placebo No-CT Group
Hide Arm/Group Description:
Patients received up to 13 doses (D) of GSK1572932 ASCI, 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).
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).
Overall Number of Participants Analyzed 731 365
Measure Type: Number
Unit of Measure: events/person-years
0.084 0.086
6.Secondary Outcome
Title Person Year Rate (PYAR) as Regards Overall-survival (OS) in the CT Population
Hide Description OS was defined as the time interval from randomization to the date of death, irrespective of the cause of death. Patients still alive were censored at the last visit they were known to be alive. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.
Time Frame From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
Arm/Group Title GSK1572932 CT Group Placebo CT Group
Hide Arm/Group Description:
Patients received up to 13 doses (D) of GSK1572932, 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).
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).
Overall Number of Participants Analyzed 784 392
Measure Type: Number
Unit of Measure: events/person-years
0.08 0.076
7.Secondary Outcome
Title Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the Overall Population
Hide Description LCSS was defined as the time interval from randomization to the date of death due to lung cancer. Deaths due to other or unknown causes were censored at the date of death. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.
Time Frame From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
Arm/Group Title GSK1572932 Group Placebo Group
Hide Arm/Group Description:
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Overall Number of Participants Analyzed 1515 757
Measure Type: Number
Unit of Measure: events/person-years
0.064 0.061
8.Secondary Outcome
Title Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the No-CT Population
Hide Description LCSS was defined as the time interval from randomization to the date of death due to lung cancer. Deaths due to other or unknown causes were censored at the date of death. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.
Time Frame From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
Arm/Group Title GSK1572932 No-CT Group Placebo No-CT Group
Hide Arm/Group Description:
Patients received up to 13 doses (D) of GSK1572932 ASCI, 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).
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).
Overall Number of Participants Analyzed 731 365
Measure Type: Number
Unit of Measure: events/person-years
0.064 0.06
9.Secondary Outcome
Title Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the CT Population
Hide Description LCSS was defined as the time interval from randomization to the date of death due to lung cancer. Deaths due to other or unknown causes were censored at the date of death. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.
Time Frame From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
Arm/Group Title GSK1572932 CT Group Placebo CT Group
Hide Arm/Group Description:
Patients received up to 13 doses (D) of GSK1572932, 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).
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).
Overall Number of Participants Analyzed 784 392
Measure Type: Number
Unit of Measure: events/person-years
0.063 0.063
10.Secondary Outcome
Title Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the Overall Population
Hide Description DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence [any tumor arising in contralateral lung or outside hemithorax]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. Median DFS KMEs in % were obtained non-parametrically by Kaplan-Meier method and confidence intervals (CIs) calculated using the Greenwood formula for standard error computation.
Time Frame KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment. Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
Arm/Group Title GSK1572932 Group Placebo Group
Hide Arm/Group Description:
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Overall Number of Participants Analyzed 1515 757
Median (95% Confidence Interval)
Unit of Measure: percent probability
DFS KME at 2Y - Overall Population
65.57
(63.08 to 67.95)
65.5
(61.94 to 68.81)
DFS KME at 3Y - Overall Population
59.97
(57.3 to 62.53)
60.42
(56.62 to 64)
DFS KME at 4Y - Overall Population
56.72
(53.8 to 59.54)
57.19
(53.07 to 61.1)
DFS KME at 5Y - Overall Population
51.73
(47.66 to 55.64)
49.56
(42.87 to 55.88)
11.Secondary Outcome
Title Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the No-CT Population
Hide Description DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence [any tumor arising in contralateral lung or outside hemithorax]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. Median DFS KMEs in % were obtained non-parametrically by Kaplan-Meier method and confidence intervals (CIs) calculated using the Greenwood formula for standard error computation.
Time Frame KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
Arm/Group Title GSK1572932 No-CT Group Placebo No-CT Group
Hide Arm/Group Description:
Patients received up to 13 doses (D) of GSK1572932 ASCI, 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).
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).
Overall Number of Participants Analyzed 731 365
Median (95% Confidence Interval)
Unit of Measure: percent probability
DFS KME at 2Y - No-CT Population
66.03
(62.39 to 69.4)
63.96
(58.72 to 68.72)
DFS KME at 3Y - No-CT Population
59.6
(55.7 to 63.27)
57.62
(52.02 to 62.81)
DFS KME at 4Y - No-CT Population
55.4
(51.06 to 59.52)
54.85
(48.98 to 60.33)
DFS KME at 5Y - No-CT Population
49.72
(43.44 to 55.67)
44.59
(34.64 to 54.05)
12.Secondary Outcome
Title Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the CT Population
Hide Description DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional & distant metastasis & 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; & distant recurrence [any tumor arising in contralateral lung or outside hemithorax]). Deaths occurring without prior documentation of recurrence were considered as event & not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. Median DFS KMEs in % were obtained non-parametrically by Kaplan-Meier method and confidence intervals (CIs) calculated using the Greenwood formula for standard error computation.
Time Frame KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment. Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
Arm/Group Title GSK1572932 CT Group Placebo CT Group
Hide Arm/Group Description:
Patients received up to 13 doses (D) of GSK1572932, 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).
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).
Overall Number of Participants Analyzed 784 392
Median (95% Confidence Interval)
Unit of Measure: percent probability
DFS KME at 2Y - CT Population
65.17
(61.67 to 68.43)
66.94
(61.98 to 71.41)
DFS KME at 3Y - CT Population
60.39
(56.68 to 63.89)
63.09
(57.84 to 67.87)
DFS KME at 4Y - CT Population
58.17
(54.22 to 61.9)
59.3
(53.33 to 64.76)
DFS KME at 5Y - CT Population
53.64
(48.28 to 58.7)
54.8
(46.44 to 62.39)
13.Secondary Outcome
Title Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the Overall Population
Hide Description DFSS was defined as the interval from randomization to the date of disease recurrence or death due to lung cancer. Patients who had died due to another cause than lung cancer were censored on their date of death and patients alive at the time of analysis were censored on the date of last assessment. Patients with no assessment post-randomization were censored on the date of randomization. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.
Time Frame From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
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Hide Analysis Population Description
The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
Arm/Group Title GSK1572932 Group Placebo Group
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Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Overall Number of Participants Analyzed 1515 757
Measure Type: Number
Unit of Measure: events/person-years
0.159 0.154
14.Secondary Outcome
Title Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the No-CT Population
Hide Description DFSS was defined as the interval from randomization to the date of disease recurrence or death due to lung cancer. Patients who had died due to another cause than lung cancer were censored on their date of death and patients alive at the time of analysis were censored on the date of last assessment. Patients with no assessment post-randomization were censored on the date of randomization. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.
Time Frame From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
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Hide Analysis Population Description
The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
Arm/Group Title GSK1572932 No-CT Group Placebo No-CT Group
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Patients received up to 13 doses (D) of GSK1572932 ASCI, 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).
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).
Overall Number of Participants Analyzed 731 365
Measure Type: Number
Unit of Measure: events/person-years
0.155 0.159
15.Secondary Outcome
Title Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the CT Population
Hide Description DFSS was defined as the interval from randomization to the date of disease recurrence or death due to lung cancer. Patients who had died due to another cause than lung cancer were censored on their date of death and patients alive at the time of analysis were censored on the date of last assessment. Patients with no assessment post-randomization were censored on the date of randomization. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.
Time Frame Period of follow-up was from administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
Arm/Group Title GSK1572932 CT Group Placebo CT Group
Hide Arm/Group Description:
Patients received up to 13 doses (D) of GSK1572932, 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).
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).
Overall Number of Participants Analyzed 784 392
Measure Type: Number
Unit of Measure: events/person-years
0.162 0.149
16.Secondary Outcome
Title Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+)
Hide Description A seropositive subject for anti-MAGE-A3 antibodies was a subject with anti-MAGE-A3 antibodies >= the seropositivity cut-off of 27 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL).
Time Frame Pre-treatment (PRE), at Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (At 12M post W120)
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Hide Analysis Population Description
The According-To-Protocol (ATP) population for immunogenicity including all evaluable patients (meeting all eligibility criteria, complying with protocol defined procedures and intervals, with no elimination criteria during the study) who received at least the 4 first doses and for whom data were available for the considered assay and time point.
Arm/Group Title GSK1572932 Group Placebo Group
Hide Arm/Group Description:
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks
Overall Number of Participants Analyzed 1184 614
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-MAGE-A3 S+, PRE Number Analyzed 1184 participants 614 participants
105
   8.9%
53
   8.6%
Anti-MAGE-A3 S+, W6 Number Analyzed 945 participants 548 participants
929
  98.3%
43
   7.8%
Anti-MAGE-A3 S+, W12 Number Analyzed 925 participants 491 participants
921
  99.6%
42
   8.6%
Anti-MAGE-A3 S+, M9 Number Analyzed 633 participants 352 participants
631
  99.7%
30
   8.5%
Anti-MAGE-A3 S+, M12 Number Analyzed 538 participants 279 participants
536
  99.6%
19
   6.8%
Anti-MAGE-A3 S+, M18 Number Analyzed 420 participants 229 participants
419
  99.8%
15
   6.6%
Anti-MAGE-A3 S+, M30 Number Analyzed 384 participants 222 participants
383
  99.7%
17
   7.7%
Anti-MAGE-A3 S+, at 12M post W120 Number Analyzed 76 participants 47 participants
75
  98.7%
5
  10.6%
17.Secondary Outcome
Title Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR)
Hide Description A seropositive/seronegative subject for anti-MAGE-A3 antibodies was a subject with anti-MAGE-A3 antibodies >=/< the seropositivity cut-off of 27 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL). A humoral responder as regards anti-MAGE-A3 antibodies was defined as 1) for initially seronegative patients, a patient with post-administration Anti-MAGE-A3 antibody concentration >= 27 EL.U/mL; 2) for initially seropositive patients: post-treatment administration antibody concentration >= 2 fold the pre-treatment antibody concentration.
Time Frame At Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)
Hide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol (ATP) population for immunogenicity including all evaluable patients (meeting all eligibility criteria, complying with protocol defined procedures and intervals, with no elimination criteria during the study) who received at least the 4 first doses and for whom data were available for the considered assay and time point.
Arm/Group Title GSK1572932 Group Placebo Group
Hide Arm/Group Description:
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Overall Number of Participants Analyzed 942 548
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-MAGE-A3 HR, W6 Number Analyzed 942 participants 548 participants
922
  97.9%
10
   1.8%
Anti-MAGE-A3 HR, W12 Number Analyzed 920 participants 491 participants
916
  99.6%
15
   3.1%
Anti-MAGE-A3 HR, M9 Number Analyzed 630 participants 352 participants
627
  99.5%
13
   3.7%
Anti-MAGE-A3 HR, M12 Number Analyzed 537 participants 279 participants
534
  99.4%
6
   2.2%
Anti-MAGE-A3 HR, M18 Number Analyzed 420 participants 229 participants
417
  99.3%
7
   3.1%
Anti-MAGE-A3 HR, M30 Number Analyzed 382 participants 222 participants
380
  99.5%
8
   3.6%
Anti-MAGE-A3 HR, at 12M post W120 Number Analyzed 76 participants 47 participants
75
  98.7%
3
   6.4%
18.Secondary Outcome
Title Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+)
Hide Description A seropositive subject for anti-PD antibodies was a subject with anti-PD antibodies >= the seropositivity cut-off of 100 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL).
Time Frame Pre-treatment (PRE), at Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)
Hide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol (ATP) population for immunogenicity including all evaluable patients (meeting all eligibility criteria, complying with protocol defined procedures and intervals, with no elimination criteria during the study) who received at least the 4 first doses and for whom data were available for the considered assay and time point.
Arm/Group Title GSK1572932 Group Placebo Group
Hide Arm/Group Description:
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Overall Number of Participants Analyzed 1096 554
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-PD S+, PRE Number Analyzed 1096 participants 554 participants
381
  34.8%
210
  37.9%
Anti-PD S+, W6 Number Analyzed 967 participants 493 participants
958
  99.1%
195
  39.6%
Anti-PD S+, W12 Number Analyzed 864 participants 436 participants
860
  99.5%
176
  40.4%
Anti-PD S+, M9 Number Analyzed 582 participants 311 participants
580
  99.7%
133
  42.8%
Anti-PD S+, M12 Number Analyzed 485 participants 243 participants
483
  99.6%
101
  41.6%
Anti-PD S+, M18 Number Analyzed 376 participants 197 participants
375
  99.7%
77
  39.1%
Anti-PD S+, M30 Number Analyzed 358 participants 189 participants
357
  99.7%
75
  39.7%
Anti-PD S+, at 12M post W120 Number Analyzed 78 participants 46 participants
77
  98.7%
17
  37.0%
19.Secondary Outcome
Title Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR)
Hide Description A seropositive/seronegative subject for anti-PD antibodies was a subject with anti-PD antibodies ≥/< the seropositivity cut-off of 100 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL). A humoral responder as regards anti-PD antibodies was defined as 1) for initially seronegative patients, a patient with post-administration anti-PD antibody concentration ≥ 100 EL.U/mL; 2) for initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration.
Time Frame At Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)
Hide Outcome Measure Data
Hide Analysis Population Description
The According-To-Protocol (ATP) population for immunogenicity including all evaluable patients (meeting all eligibility criteria, complying with protocol defined procedures and intervals, with no elimination criteria during the study) who received at least the 4 first doses and for whom data were available for the considered assay and time point.
Arm/Group Title GSK1572932 Group Placebo Group
Hide Arm/Group Description:
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Overall Number of Participants Analyzed 962 490
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-PD HR, W6 Number Analyzed 962 participants 490 participants
945
  98.2%
27
   5.5%
Anti-PD HR, W12 Number Analyzed 859 participants 432 participants
853
  99.3%
35
   8.1%
Anti-PD HR, M9 Number Analyzed 579 participants 307 participants
575
  99.3%
26
   8.5%
Anti-PD HR, M12 Number Analyzed 482 participants 240 participants
479
  99.4%
19
   7.9%
Anti-PD HR, M18 Number Analyzed 374 participants 194 participants
370
  98.9%
21
  10.8%
Anti-PD HR, M30 Number Analyzed 354 participants 186 participants
352
  99.4%
17
   9.1%
Anti-PD HR, at 12M post W120 Number Analyzed 78 participants 46 participants
77
  98.7%
4
   8.7%
20.Secondary Outcome
Title Health-related Quality of Life (HQL) Scores
Hide Description HQL was assessed using the EQ-5D generic health state classification and valuation system. The number and percentage of patients with each score within each dimension of the EQ-5D questionnaire (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) were tabulated at each assessment for each group. Each of these scores can take 3 levels: no problem (level 1), moderate problem (level 2) or extreme problem (level 3). Resulting descriptive mean and standard deviation (SD) for the EQ-5D Utility Value (EQ-5D UV) were tabulated. Valid EQ-5D data were defined as questionnaires assessed 1) on day of and before treatment administration; or 2) on day after treatment administration for W0, W6, W12; or 3)during follow-up visits or at time of recurrence. The EQ-5D total score ranges from -0.016 (worst health state) to 1.000 (best health state).
Time Frame At Week (W) 0 on day of treatment (DoT) (W0 DoT), W0 on day post treatment (DpT) (W0 DpT), W6 DoT, W6 DpT, W12 DoT, W12 DpT, Month (M) 6, M9, M12, M24, 6M post W120, at recurrence, and at 12M post W120
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
Arm/Group Title GSK1572932 Group Placebo Group
Hide Arm/Group Description:
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Overall Number of Participants Analyzed 226 103
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
EQ-5D UV, At W0 DoT Number Analyzed 226 participants 103 participants
0.83  (0.152) 0.823  (0.189)
EQ-5D UV, At W0 DpT Number Analyzed 206 participants 93 participants
0.788  (0.182) 0.838  (0.177)
EQ-5D UV, At W6 DoT Number Analyzed 215 participants 99 participants
0.837  (0.182) 0.825  (0.191)
EQ-5D UV, At W6 DpT Number Analyzed 188 participants 94 participants
0.798  (0.205) 0.835  (0.176)
EQ-5D UV, At W12 DoT Number Analyzed 201 participants 97 participants
0.848  (0.158) 0.811  (0.236)
EQ-5D UV, At W12 DpT Number Analyzed 186 participants 87 participants
0.841  (0.152) 0.831  (0.211)
EQ-5D UV, At M6 Number Analyzed 176 participants 84 participants
0.847  (0.182) 0.825  (0.236)
EQ-5D UV, At M9 Number Analyzed 173 participants 81 participants
0.84  (0.197) 0.81  (0.219)
EQ-5D UV, At M12 Number Analyzed 146 participants 69 participants
0.857  (0.166) 0.824  (0.214)
EQ-5D UV, At M24 Number Analyzed 102 participants 50 participants
0.855  (0.179) 0.865  (0.145)
EQ-5D UV, At 6M post W120 Number Analyzed 7 participants 3 participants
0.723  (0.298) 0.679  (0.073)
EQ-5D UV, At recurrence Number Analyzed 41 participants 14 participants
0.662  (0.343) 0.785  (0.159)
EQ-5D UV, At 12M post W120 Number Analyzed 16 participants 5 participants
0.753  (0.199) 0.777  (0.395)
21.Secondary Outcome
Title Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
Hide Description The status of each patient as regards ALT laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Time Frame From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
Arm/Group Title GSK1572932 Group Placebo Group
Hide Arm/Group Description:
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Overall Number of Participants Analyzed 1515 757
Measure Type: Count of Participants
Unit of Measure: Participants
ALT - SCR UNK; DLP G0
1
   0.1%
0
   0.0%
ALT - SCR UNK; DLP G1
1
   0.1%
1
   0.1%
ALT - SCR UNK; DLP G2
0
   0.0%
0
   0.0%
ALT - SCR UNK; DLP G3
0
   0.0%
0
   0.0%
ALT - SCR UNK; DLP G4
0
   0.0%
0
   0.0%
ALT - SCR UNK; DLP UNK
3
   0.2%
1
   0.1%
ALT - SCR G0; DLP G0
1133
  74.8%
588
  77.7%
ALT - SCR G0; DLP G1
162
  10.7%
77
  10.2%
ALT - SCR G0; DLP G2
17
   1.1%
8
   1.1%
ALT - SCR G0; DLP G3
7
   0.5%
7
   0.9%
ALT - SCR G0; DLP G4
1
   0.1%
1
   0.1%
ALT - SCR G0; DLP UNK
113
   7.5%
37
   4.9%
ALT - SCR G1; DLP G0
34
   2.2%
14
   1.8%
ALT - SCR G1; DLP G1
32
   2.1%
17
   2.2%
ALT - SCR G1; DLP G2
4
   0.3%
3
   0.4%
ALT - SCR G1; DLP G3
1
   0.1%
2
   0.3%
ALT - SCR G1; DLP G4
0
   0.0%
0
   0.0%
ALT - SCR G1; DLP UNK
4
   0.3%
1
   0.1%
ALT - SCR G2; DLP G0
0
   0.0%
0
   0.0%
ALT - SCR G2; DLP G1
1
   0.1%
0
   0.0%
ALT - SCR G2; DLP G2
1
   0.1%
0
   0.0%
ALT - SCR G2; DLP G3
0
   0.0%
0
   0.0%
ALT - SCR G2; DLP G4
0
   0.0%
0
   0.0%
ALT - SCR G2; DLP UNK
0
   0.0%
0
   0.0%
22.Secondary Outcome
Title Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
Hide Description The status of each patient as regards AST laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Time Frame From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
Arm/Group Title GSK1572932 Group Placebo Group
Hide Arm/Group Description:
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Overall Number of Participants Analyzed 1515 757
Measure Type: Count of Participants
Unit of Measure: Participants
AST - SCR UNK; DLP G0
12
   0.8%
4
   0.5%
AST - SCR UNK; DLP G1
5
   0.3%
2
   0.3%
AST - SCR UNK; DLP G2
0
   0.0%
0
   0.0%
AST - SCR UNK; DLP G3
0
   0.0%
0
   0.0%
AST - SCR UNK; DLP G4
0
   0.0%
0
   0.0%
AST - SCR UNK; DLP UNK
5
   0.3%
2
   0.3%
AST - SCR G0; DLP G0
1170
  77.2%
579
  76.5%
AST - SCR G0; DLP G1
136
   9.0%
84
  11.1%
AST - SCR G0; DLP G2
6
   0.4%
4
   0.5%
AST - SCR G0; DLP G3
8
   0.5%
5
   0.7%
AST - SCR G0; DLP G4
2
   0.1%
1
   0.1%
AST - SCR G0; DLP UNK
111
   7.3%
37
   4.9%
AST - SCR G1; DLP G0
26
   1.7%
19
   2.5%
AST - SCR G1; DLP G1
25
   1.7%
16
   2.1%
AST - SCR G1; DLP G2
5
   0.3%
2
   0.3%
AST - SCR G1; DLP G3
0
   0.0%
1
   0.1%
AST - SCR G1; DLP G4
0
   0.0%
0
   0.0%
AST - SCR G1; DLP UNK
2
   0.1%
1
   0.1%
AST - SCR G2; DLP G0
0
   0.0%
0
   0.0%
AST - SCR G2; DLP G1
0
   0.0%
0
   0.0%
AST - SCR G2; DLP G2
0
   0.0%
0
   0.0%
AST - SCR G2; DLP G3
1
   0.1%
0
   0.0%
AST - SCR G2; DLP G4
0
   0.0%
0
   0.0%
AST - SCR G2; DLP UNK
1
   0.1%
0
   0.0%
23.Secondary Outcome
Title Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
Hide Description The status of each patient as regards ALKP laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Time Frame From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
Arm/Group Title GSK1572932 Group Placebo Group
Hide Arm/Group Description:
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Overall Number of Participants Analyzed 1515 757
Measure Type: Count of Participants
Unit of Measure: Participants
ALKP - SCR UNK; DLP G0
21
   1.4%
3
   0.4%
ALKP - SCR UNK; DLP G1
0
   0.0%
0
   0.0%
ALKP - SCR UNK; DLP G2
0
   0.0%
0
   0.0%
ALKP - SCR UNK; DLP G3
1
   0.1%
0
   0.0%
ALKP - SCR UNK; DLP G4
0
   0.0%
0
   0.0%
ALKP - SCR UNK; DLP UNK
5
   0.3%
3
   0.4%
ALKP - SCR G0; DLP G0
1121
  74.0%
569
  75.2%
ALKP - SCR G0; DLP G1
99
   6.5%
63
   8.3%
ALKP - SCR G0; DLP G2
3
   0.2%
2
   0.3%
ALKP - SCR G0; DLP G3
1
   0.1%
0
   0.0%
ALKP - SCR G0; DLP G4
0
   0.0%
0
   0.0%
ALKP - SCR G0; DLP UNK
107
   7.1%
39
   5.2%
ALKP - SCR G1; DLP G0
63
   4.2%
35
   4.6%
ALKP - SCR G1; DLP G1
79
   5.2%
38
   5.0%
ALKP - SCR G1; DLP G2
1
   0.1%
0
   0.0%
ALKP - SCR G1; DLP G3
1
   0.1%
0
   0.0%
ALKP - SCR G1; DLP G4
0
   0.0%
0
   0.0%
ALKP - SCR G1; DLP UNK
11
   0.7%
4
   0.5%
ALKP - SCR G2; DLP G0
0
   0.0%
0
   0.0%
ALKP - SCR G2; DLP G1
2
   0.1%
1
   0.1%
ALKP - SCR G2; DLP G2
0
   0.0%
0
   0.0%
ALKP - SCR G2; DLP G3
0
   0.0%
0
   0.0%
ALKP - SCR G2; DLP G4
0
   0.0%
0
   0.0%
ALKP - SCR G2; DLP UNK
0
   0.0%
0
   0.0%
24.Secondary Outcome
Title Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade
Hide Description The status of each patient as regards BIL laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0) and G1. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Time Frame From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
Arm/Group Title GSK1572932 Group Placebo Group
Hide Arm/Group Description:
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Overall Number of Participants Analyzed 1515 757
Measure Type: Count of Participants
Unit of Measure: Participants
BIL - SCR UNK; DLP G0
9
   0.6%
2
   0.3%
BIL - SCR UNK; DLP G1
1
   0.1%
0
   0.0%
BIL - SCR UNK; DLP G2
0
   0.0%
0
   0.0%
BIL - SCR UNK; DLP G3
0
   0.0%
0
   0.0%
BIL - SCR UNK; DLP G4
0
   0.0%
0
   0.0%
BIL - SCR UNK; DLP UNK
4
   0.3%
2
   0.3%
BIL - SCR G0; DLP G0
1275
  84.2%
661
  87.3%
BIL - SCR G0; DLP G1
74
   4.9%
28
   3.7%
BIL - SCR G0; DLP G2
11
   0.7%
9
   1.2%
BIL - SCR G0; DLP G3
1
   0.1%
2
   0.3%
BIL - SCR G0; DLP G4
1
   0.1%
0
   0.0%
BIL - SCR G0; DLP UNK
114
   7.5%
37
   4.9%
BIL - SCR G1; DLP G0
10
   0.7%
5
   0.7%
BIL - SCR G1; DLP G1
8
   0.5%
9
   1.2%
BIL - SCR G1; DLP G2
5
   0.3%
1
   0.1%
BIL - SCR G1; DLP G3
1
   0.1%
0
   0.0%
BIL - SCR G1; DLP G4
0
   0.0%
0
   0.0%
BIL - SCR G1; DLP UNK
1
   0.1%
1
   0.1%
25.Secondary Outcome
Title Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
Hide Description The status of each patient as regards CREA laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Time Frame From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
Arm/Group Title GSK1572932 Group Placebo Group
Hide Arm/Group Description:
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Overall Number of Participants Analyzed 1515 757
Measure Type: Count of Participants
Unit of Measure: Participants
CREA - SCR UNK; DLP G0
2
   0.1%
0
   0.0%
CREA - SCR UNK; DLP G1
0
   0.0%
0
   0.0%
CREA - SCR UNK; DLP G2
0
   0.0%
0
   0.0%
CREA - SCR UNK; DLP G3
0
   0.0%
0
   0.0%
CREA - SCR UNK; DLP G4
2
   0.1%
0
   0.0%
CREA - SCR UNK; DLP UNK
1139
  75.2%
577
  76.2%
CREA - SCR G0; DLP G0
126
   8.3%
74
   9.8%
CREA - SCR G0; DLP G1
9
   0.6%
3
   0.4%
CREA - SCR G0; DLP G2
3
   0.2%
1
   0.1%
CREA - SCR G0; DLP G3
1
   0.1%
0
   0.0%
CREA - SCR G0; DLP G4
103
   6.8%
32
   4.2%
CREA - SCR G0; DLP UNK
27
   1.8%
14
   1.8%
CREA - SCR G1; DLP G0
72
   4.8%
44
   5.8%
CREA - SCR G1; DLP G1
11
   0.7%
6
   0.8%
CREA - SCR G1; DLP G2
0
   0.0%
0
   0.0%
CREA - SCR G1; DLP G3
1
   0.1%
0
   0.0%
CREA - SCR G1; DLP G4
6
   0.4%
4
   0.5%
CREA - SCR G1; DLP UNK
0
   0.0%
0
   0.0%
CREA - SCR G2; DLP G0
7
   0.5%
2
   0.3%
CREA - SCR G2; DLP G1
6
   0.4%
0
   0.0%
CREA - SCR G2; DLP G2
0
   0.0%
0
   0.0%
CREA - SCR G2; DLP G3
0
   0.0%
0
   0.0%
CREA - SCR G2; DLP G4
0
   0.0%
0
   0.0%
CREA - SCR G2; DLP UNK
0
   0.0%
0
   0.0%
26.Secondary Outcome
Title Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
Hide Description The status of each patient as regards HGB laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Time Frame From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
Arm/Group Title GSK1572932 Group Placebo Group
Hide Arm/Group Description:
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Overall Number of Participants Analyzed 1515 757
Measure Type: Count of Participants
Unit of Measure: Participants
HGB - SCR UNK; DLP G0
3
   0.2%
0
   0.0%
HGB - SCR UNK; DLP G1
1
   0.1%
0
   0.0%
HGB - SCR UNK; DLP G2
0
   0.0%
0
   0.0%
HGB - SCR UNK; DLP G3
0
   0.0%
0
   0.0%
HGB - SCR UNK; DLP G4
0
   0.0%
0
   0.0%
HGB - SCR UNK; DLP UNK
3
   0.2%
0
   0.0%
HGB - SCR G0; DLP G0
534
  35.2%
274
  36.2%
HGB - SCR G0; DLP G1
70
   4.6%
26
   3.4%
HGB - SCR G0; DLP G2
9
   0.6%
5
   0.7%
HGB - SCR G0; DLP G3
1
   0.1%
1
   0.1%
HGB - SCR G0; DLP G4
0
   0.0%
2
   0.3%
HGB - SCR G0; DLP UNK
50
   3.3%
19
   2.5%
HGB - SCR G1; DLP G0
342
  22.6%
187
  24.7%
HGB - SCR G1; DLP G1
310
  20.5%
142
  18.8%
HGB - SCR G1; DLP G2
17
   1.1%
14
   1.8%
HGB - SCR G1; DLP G3
6
   0.4%
3
   0.4%
HGB - SCR G1; DLP G4
2
   0.1%
0
   0.0%
HGB - SCR G1; DLP UNK
49
   3.2%
15
   2.0%
HGB - SCR G2; DLP G0
29
   1.9%
30
   4.0%
HGB - SCR G2; DLP G1
63
   4.2%
31
   4.1%
HGB - SCR G2; DLP G2
12
   0.8%
3
   0.4%
HGB - SCR G2; DLP G3
1
   0.1%
3
   0.4%
HGB - SCR G2; DLP G4
1
   0.1%
0
   0.0%
HGB - SCR G2; DLP UNK
6
   0.4%
0
   0.0%
HGB - SCR G3; DLP G0
2
   0.1%
0
   0.0%
HGB - SCR G3; DLP G1
3
   0.2%
1
   0.1%
HGB - SCR G3; DLP G2
1
   0.1%
1
   0.1%
HGB - SCR G3; DLP G3
0
   0.0%
0
   0.0%
HGB - SCR G3; DLP G4
0
   0.0%
0
   0.0%
HGB - SCR G3; DLP UNK
0
   0.0%
0
   0.0%
27.Secondary Outcome
Title Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
Hide Description The status of each patient as regards LEU laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Time Frame From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
Arm/Group Title GSK1572932 Group Placebo Group
Hide Arm/Group Description:
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Overall Number of Participants Analyzed 1515 757
Measure Type: Count of Participants
Unit of Measure: Participants
LEU - SCR UNK; DLP G0
1
   0.1%
0
   0.0%
LEU - SCR UNK; DLP G1
0
   0.0%
0
   0.0%
LEU - SCR UNK; DLP G2
0
   0.0%
0
   0.0%
LEU - SCR UNK; DLP G3
0
   0.0%
0
   0.0%
LEU - SCR UNK; DLP G4
0
   0.0%
0
   0.0%
LEU - SCR UNK; DLP UNK
1
   0.1%
0
   0.0%
LEU - SCR G0; DLP G0
1259
  83.1%
652
  86.1%
LEU - SCR G0; DLP G1
45
   3.0%
29
   3.8%
LEU - SCR G0; DLP G2
4
   0.3%
2
   0.3%
LEU - SCR G0; DLP G3
2
   0.1%
0
   0.0%
LEU - SCR G0; DLP G4
6
   0.4%
2
   0.3%
LEU - SCR G0; DLP UNK
98
   6.5%
32
   4.2%
LEU - SCR G1; DLP G0
54
   3.6%
24
   3.2%
LEU - SCR G1; DLP G1
21
   1.4%
5
   0.7%
LEU - SCR G1; DLP G2
2
   0.1%
1
   0.1%
LEU - SCR G1; DLP G3
0
   0.0%
0
   0.0%
LEU - SCR G1; DLP G4
0
   0.0%
1
   0.1%
LEU - SCR G1; DLP UNK
4
   0.3%
0
   0.0%
LEU - SCR G2; DLP G0
13
   0.9%
6
   0.8%
LEU - SCR G2; DLP G1
3
   0.2%
2
   0.3%
LEU - SCR G2; DLP G2
2
   0.1%
0
   0.0%
LEU - SCR G2; DLP G3
0
   0.0%
0
   0.0%
LEU - SCR G2; DLP G4
0
   0.0%
0
   0.0%
LEU - SCR G2; DLP UNK
0
   0.0%
0
   0.0%
LEU - SCR G3; DLP G0
0
   0.0%
1
   0.1%
LEU - SCR G3; DLP G1
0
   0.0%
0
   0.0%
LEU - SCR G3; DLP G2
0
   0.0%
0
   0.0%
LEU - SCR G3; DLP G3
0
   0.0%
0
   0.0%
LEU - SCR G3; DLP G4
0
   0.0%
0
   0.0%
LEU - SCR G3; DLP UNK
0
   0.0%
0
   0.0%
28.Secondary Outcome
Title Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
Hide Description The status of each patient as regards LYM laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Time Frame From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
Arm/Group Title GSK1572932 Group Placebo Group
Hide Arm/Group Description:
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Overall Number of Participants Analyzed 1515 757
Measure Type: Count of Participants
Unit of Measure: Participants
LYM - SCR UNK; DLP G0
12
   0.8%
3
   0.4%
LYM - SCR UNK; DLP G1
3
   0.2%
1
   0.1%
LYM - SCR UNK; DLP G2
0
   0.0%
0
   0.0%
LYM - SCR UNK; DLP G3
0
   0.0%
0
   0.0%
LYM - SCR UNK; DLP G4
0
   0.0%
0
   0.0%
LYM - SCR UNK; DLP UNK
4
   0.3%
2
   0.3%
LYM - SCR G0; DLP G0
999
  65.9%
518
  68.4%
LYM - SCR G0; DLP G1
160
  10.6%
89
  11.8%
LYM - SCR G0; DLP G2
40
   2.6%
16
   2.1%
LYM - SCR G0; DLP G3
5
   0.3%
0
   0.0%
LYM - SCR G0; DLP G4
0
   0.0%
0
   0.0%
LYM - SCR G0; DLP UNK
96
   6.3%
35
   4.6%
LYM - SCR G1; DLP G0
47
   3.1%
27
   3.6%
LYM - SCR G1; DLP G1
86
   5.7%
42
   5.5%
LYM - SCR G1; DLP G2
15
   1.0%
4
   0.5%
LYM - SCR G1; DLP G3
1
   0.1%
4
   0.5%
LYM - SCR G1; DLP G4
2
   0.1%
0
   0.0%
LYM - SCR G1; DLP UNK
20
   1.3%
5
   0.7%
LYM - SCR G2; DLP G0
3
   0.2%
1
   0.1%
LYM - SCR G2; DLP G1
7
   0.5%
2
   0.3%
LYM - SCR G2; DLP G2
4
   0.3%
3
   0.4%
LYM - SCR G2; DLP G3
2
   0.1%
1
   0.1%
LYM - SCR G2; DLP G4
0
   0.0%
0
   0.0%
LYM - SCR G2; DLP UNK
0
   0.0%
1
   0.1%
LYM - SCR G3; DLP G0
4
   0.3%
1
   0.1%
LYM - SCR G3; DLP G1
1
   0.1%
2
   0.3%
LYM - SCR G3; DLP G2
3
   0.2%
0
   0.0%
LYM - SCR G3; DLP G3
1
   0.1%
0
   0.0%
LYM - SCR G3; DLP G4
0
   0.0%
0
   0.0%
LYM - SCR G3; DLP UNK
0
   0.0%
0
   0.0%
29.Secondary Outcome
Title Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
Hide Description The status of each patient as regards NEU laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2, G3 and G4. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Time Frame From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
Arm/Group Title GSK1572932 Group Placebo Group
Hide Arm/Group Description:
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Overall Number of Participants Analyzed 1515 757
Measure Type: Count of Participants
Unit of Measure: Participants
NEU - SCR UNK; DLP G0
12
   0.8%
3
   0.4%
NEU - SCR UNK; DLP G1
0
   0.0%
0
   0.0%
NEU - SCR UNK; DLP G2
0
   0.0%
0
   0.0%
NEU - SCR UNK; DLP G3
0
   0.0%
0
   0.0%
NEU - SCR UNK; DLP G4
0
   0.0%
0
   0.0%
NEU - SCR UNK; DLP UNK
1
   0.1%
2
   0.3%
NEU - SCR G0; DLP G0
1200
  79.2%
625
  82.6%
NEU - SCR G0; DLP G1
47
   3.1%
28
   3.7%
NEU - SCR G0; DLP G2
1
   0.1%
3
   0.4%
NEU - SCR G0; DLP G3
2
   0.1%
1
   0.1%
NEU - SCR G0; DLP G4
3
   0.2%
1
   0.1%
NEU - SCR G0; DLP UNK
111
   7.3%
37
   4.9%
NEU - SCR G1; DLP G0
56
   3.7%
23
   3.0%
NEU - SCR G1; DLP G1
31
   2.0%
10
   1.3%
NEU - SCR G1; DLP G2
3
   0.2%
1
   0.1%
NEU - SCR G1; DLP G3
0
   0.0%
0
   0.0%
NEU - SCR G1; DLP G4
0
   0.0%
0
   0.0%
NEU - SCR G1; DLP UNK
3
   0.2%
2
   0.3%
NEU - SCR G2; DLP G0
32
   2.1%
16
   2.1%
NEU - SCR G2; DLP G1
5
   0.3%
1
   0.1%
NEU - SCR G2; DLP G2
2
   0.1%
2
   0.3%
NEU - SCR G2; DLP G3
0
   0.0%
0
   0.0%
NEU - SCR G2; DLP G4
0
   0.0%
0
   0.0%
NEU - SCR G2; DLP UNK
1
   0.1%
1
   0.1%
NEU - SCR G3; DLP G0
3
   0.2%
1
   0.1%
NEU - SCR G3; DLP G1
0
   0.0%
0
   0.0%
NEU - SCR G3; DLP G2
0
   0.0%
0
   0.0%
NEU - SCR G3; DLP G3
0
   0.0%
0
   0.0%
NEU - SCR G3; DLP G4
0
   0.0%
0
   0.0%
NEU - SCR G3; DLP UNK
0
   0.0%
0
   0.0%
NEU - SCR G4; DLP G0
1
   0.1%
0
   0.0%
NEU - SCR G4; DLP G1
0
   0.0%
0
   0.0%
NEU - SCR G4; DLP G2
1
   0.1%
0
   0.0%
NEU - SCR G4; DLP G3
0
   0.0%
0
   0.0%
NEU - SCR G4; DLP G4
0
   0.0%
0
   0.0%
NEU - SCR G4; DLP UNK
0
   0.0%
0
   0.0%
30.Secondary Outcome
Title Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
Hide Description The status of each patient as regards PLA laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.
Time Frame From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
Arm/Group Title GSK1572932 Group Placebo Group
Hide Arm/Group Description:
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Overall Number of Participants Analyzed 1515 757
Measure Type: Count of Participants
Unit of Measure: Participants
PLA - SCR UNK; DLP G0
1
   0.1%
1
   0.1%
PLA - SCR UNK; DLP G1
0
   0.0%
0
   0.0%
PLA - SCR UNK; DLP G2
0
   0.0%
0
   0.0%
PLA - SCR UNK; DLP G3
0
   0.0%
0
   0.0%
PLA - SCR UNK; DLP G4
0
   0.0%
0
   0.0%
PLA - SCR UNK; DLP UNK
1
   0.1%
0
   0.0%
PLA - SCR G0; DLP G0
1275
  84.2%
648
  85.6%
PLA - SCR G0; DLP G1
78
   5.1%
38
   5.0%
PLA - SCR G0; DLP G2
6
   0.4%
2
   0.3%
PLA - SCR G0; DLP G3
1
   0.1%
0
   0.0%
PLA - SCR G0; DLP G4
7
   0.5%
2
   0.3%
PLA - SCR G0; DLP UNK
98
   6.5%
35
   4.6%
PLA - SCR G1; DLP G0
22
   1.5%
16
   2.1%
PLA - SCR G1; DLP G1
17
   1.1%
10
   1.3%
PLA - SCR G1; DLP G2
2
   0.1%
4
   0.5%
PLA - SCR G1; DLP G3
1
   0.1%
0
   0.0%
PLA - SCR G1; DLP G4
0
   0.0%
0
   0.0%
PLA - SCR G1; DLP UNK
5
   0.3%
0
   0.0%
PLA - SCR G3; DLP G0
1
   0.1%
1
   0.1%
PLA - SCR G3; DLP G1
0
   0.0%
0
   0.0%
PLA - SCR G3; DLP G2
0
   0.0%
0
   0.0%
PLA - SCR G3; DLP G3
0
   0.0%
0
   0.0%
PLA - SCR G3; DLP G4
0
   0.0%
0
   0.0%
PLA - SCR G3; DLP UNK
0
   0.0%
0
   0.0%
31.Secondary Outcome
Title Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP)
Hide Description An AE was any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs reported are here below tabulated irrespective of grade, as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1), G2, G3, G4 and G5. Any here below is defined as irrespective of CTC grade reported.
Time Frame Within the 31-day follow-up period post treatment administration, up to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
Arm/Group Title GSK1572932 Group Placebo Group
Hide Arm/Group Description:
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Overall Number of Participants Analyzed 1515 757
Measure Type: Count of Participants
Unit of Measure: Participants
Patients with any AEs
1369
  90.4%
556
  73.4%
Patients with G1 AEs
563
  37.2%
225
  29.7%
Patients with G2 AEs
560
  37.0%
209
  27.6%
Patients with G3 AEs
184
  12.1%
88
  11.6%
Patients with G4 AEs
49
   3.2%
26
   3.4%
Patients with G5 AEs
13
   0.9%
8
   1.1%
32.Secondary Outcome
Title Number of Patients With Serious Adverse Events (SAEs) - Up to Data Lock Point (DLP)
Hide Description A SAE is any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject, or was a Grade 4 AE according to CTC for Adverse Events, Version 3.0. Events part of natural course of lung cancer (i.e., disease progression, recurrence) were captured towards clinical efficacy assessment (CEA) and were not reported as SAEs. Death due to a progressive disease was similarly recorded towards CEA, but not as an SAE. However, if progression of lung cancer disease was greater than normally be expected, or if investigators considered that there was a causal relationship between treatment or protocol design/procedures and disease progression/ recurrence, then it was reported as SAE. Any new cancer (non-related to lung cancer) was reported as SAE.
Time Frame From screening (SCR) up to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)
Hide Outcome Measure Data
Hide Analysis Population Description
The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
Arm/Group Title GSK1572932 Group Placebo Group
Hide Arm/Group Description:
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Overall Number of Participants Analyzed 1515 757
Measure Type: Count of Participants
Unit of Measure: Participants
330
  21.8%
164
  21.7%
Time Frame From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GSK1572932 Group Placebo Group
Hide Arm/Group Description Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks. Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
All-Cause Mortality
GSK1572932 Group Placebo Group
Affected / at Risk (%) Affected / at Risk (%)
Total   30/1515 (1.98%)      17/757 (2.25%)    
Hide Serious Adverse Events
GSK1572932 Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   330/1515 (21.78%)      164/757 (21.66%)    
Blood and lymphatic system disorders     
Anaemia † 1  7/1515 (0.46%)  8 2/757 (0.26%)  2
Anaemia macrocytic † 1  1/1515 (0.07%)  3 0/757 (0.00%)  0
Hypersplenism † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Hypochromic anaemia † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Idiopathic thrombocytopenic purpura † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Lymphadenitis † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Lymphocytosis † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Neutropenia † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Thrombocytopenia † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Cardiac disorders     
Acute coronary syndrome † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Acute myocardial infarction † 1  2/1515 (0.13%)  2 2/757 (0.26%)  2
Adams-stokes syndrome † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Angina pectoris † 1  2/1515 (0.13%)  2 0/757 (0.00%)  0
Angina unstable † 1  3/1515 (0.20%)  3 3/757 (0.40%)  3
Atrial fibrillation † 1  4/1515 (0.26%)  4 3/757 (0.40%)  3
Atrial flutter † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Atrial tachycardia † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Atrioventricular block † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Atrioventricular block complete † 1  2/1515 (0.13%)  2 0/757 (0.00%)  0
Atrioventricular block second degree † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Bradyarrhythmia † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Cardiac arrest † 1  2/1515 (0.13%)  3 1/757 (0.13%)  1
Cardiac failure † 1  5/1515 (0.33%)  6 1/757 (0.13%)  1
Cardiac failure congestive † 1  1/1515 (0.07%)  1 3/757 (0.40%)  4
Cardiac fibrillation † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Cardiac flutter † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Cardio-respiratory arrest † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Cardiomyopathy † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Congestive cardiomyopathy † 1  0/1515 (0.00%)  0 1/757 (0.13%)  2
Coronary artery disease † 1  3/1515 (0.20%)  3 0/757 (0.00%)  0
Coronary artery occlusion † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Coronary artery stenosis † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Hypertensive heart disease † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Left ventricular dysfunction † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Left ventricular failure † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Mitral valve incompetence † 1  2/1515 (0.13%)  2 0/757 (0.00%)  0
Myocardial infarction † 1  4/1515 (0.26%)  6 3/757 (0.40%)  3
Myocardial ischaemia † 1  2/1515 (0.13%)  2 1/757 (0.13%)  1
Palpitations † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Pericardial effusion † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Prinzmetal angina † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Silent myocardial infarction † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Sinus bradycardia † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Stress cardiomyopathy † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Ventricular tachycardia † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Ear and labyrinth disorders     
Vertigo positional † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Endocrine disorders     
Autoimmune thyroiditis † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Hypothyroidism † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Eye disorders     
Age-related macular degeneration † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Macular fibrosis † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Retinal artery occlusion † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Retinal detachment † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Gastrointestinal disorders     
Abdominal hernia † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Abdominal pain † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Abdominal pain lower † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Abdominal pain upper † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Ascites † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Colitis ischaemic † 1  2/1515 (0.13%)  2 1/757 (0.13%)  1
Colitis microscopic † 1  2/1515 (0.13%)  2 0/757 (0.00%)  0
Colitis ulcerative † 1  2/1515 (0.13%)  2 0/757 (0.00%)  0
Constipation † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Diaphragmatic hernia † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Diarrhoea † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Diverticular perforation † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Diverticulitis intestinal haemorrhagic † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Diverticulum intestinal † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Duodenal obstruction † 1  1/1515 (0.07%)  2 0/757 (0.00%)  0
Duodenal stenosis † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Duodenal ulcer † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Duodenal ulcer haemorrhage † 1  2/1515 (0.13%)  2 1/757 (0.13%)  1
Dyspepsia † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Gastric haemorrhage † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Gastric polyps † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Gastric ulcer † 1  1/1515 (0.07%)  1 2/757 (0.26%)  2
Gastritis † 1  2/1515 (0.13%)  2 1/757 (0.13%)  1
Gastrooesophageal reflux disease † 1  5/1515 (0.33%)  5 1/757 (0.13%)  1
Haematemesis † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Hiatus hernia † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Ileus † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Inguinal hernia † 1  7/1515 (0.46%)  7 2/757 (0.26%)  2
Inguinal hernia, obstructive † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Intestinal obstruction † 1  1/1515 (0.07%)  2 1/757 (0.13%)  1
Intestinal polyp † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Large intestine polyp † 1  2/1515 (0.13%)  2 0/757 (0.00%)  0
Melaena † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Nausea † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Oesophagitis † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Oesophagitis ulcerative † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Pancreatic necrosis † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Pancreatitis acute † 1  2/1515 (0.13%)  2 1/757 (0.13%)  1
Pancreatitis chronic † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Peritoneal adhesions † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Umbilical hernia † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Vomiting † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
General disorders     
Asthenia † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Chest discomfort † 1  0/1515 (0.00%)  0 2/757 (0.26%)  2
Chest pain † 1  3/1515 (0.20%)  3 3/757 (0.40%)  3
Death † 1  2/1515 (0.13%)  2 3/757 (0.40%)  3
Euthanasia † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Fatigue † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
General physical health deterioration † 1  0/1515 (0.00%)  0 2/757 (0.26%)  2
Impaired healing † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Influenza like illness † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Mass † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Multi-organ failure † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Non-cardiac chest pain † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Oedema peripheral † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Pyrexia † 1  2/1515 (0.13%)  2 0/757 (0.00%)  0
Sudden death † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Hepatobiliary disorders     
Autoimmune hepatitis † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Bile duct stone † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Cholangitis † 1  1/1515 (0.07%)  2 0/757 (0.00%)  0
Cholangitis acute † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Cholangitis chronic † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Cholecystitis † 1  3/1515 (0.20%)  3 2/757 (0.26%)  2
Cholecystitis acute † 1  2/1515 (0.13%)  2 0/757 (0.00%)  0
Cholelithiasis † 1  4/1515 (0.26%)  4 0/757 (0.00%)  0
Hepatic failure † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Jaundice † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Portal vein thrombosis † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Immune system disorders     
Hypersensitivity † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Immune system disorder † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Infections and infestations     
Abscess † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Acute hepatitis b † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Anal abscess † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Appendicitis † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Appendicitis perforated † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Bronchiolitis † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Bronchitis † 1  3/1515 (0.20%)  3 1/757 (0.13%)  1
Bronchopneumonia † 1  2/1515 (0.13%)  2 0/757 (0.00%)  0
Bronchopulmonary aspergillosis † 1  3/1515 (0.20%)  3 1/757 (0.13%)  1
Carbuncle † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Cellulitis † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Cellulitis streptococcal † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Chest wall abscess † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Citrobacter infection † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Device related infection † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Diarrhoea infectious † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Diverticulitis † 1  2/1515 (0.13%)  2 0/757 (0.00%)  0
Enterocolitis infectious † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Erysipelas † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Gastroenteritis † 1  1/1515 (0.07%)  1 1/757 (0.13%)  2
Gastroenteritis clostridial † 1  0/1515 (0.00%)  0 2/757 (0.26%)  3
Gastroenteritis salmonella † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Hepatitis b † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Herpes zoster † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Infectious pleural effusion † 1  3/1515 (0.20%)  3 1/757 (0.13%)  1
Infective exacerbation of chronic obstructive airways diseas † 1  2/1515 (0.13%)  2 0/757 (0.00%)  0
Lobar pneumonia † 1  5/1515 (0.33%)  5 0/757 (0.00%)  0
Lower respiratory tract infection † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Lower respiratory tract infection viral † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Lung infection † 1  4/1515 (0.26%)  4 1/757 (0.13%)  1
Peritonitis † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Pneumonia † 1  26/1515 (1.72%)  27 15/757 (1.98%)  16
Pneumonia bacterial † 1  4/1515 (0.26%)  4 4/757 (0.53%)  4
Pneumonia haemophilus † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Pneumonia pseudomonas aeruginosa † 1  2/1515 (0.13%)  2 0/757 (0.00%)  0
Pneumonia staphylococcal † 1  2/1515 (0.13%)  2 1/757 (0.13%)  1
Post procedural infection † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Postoperative wound infection † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Pulmonary tuberculosis † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Q fever † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Renal abscess † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Respiratory tract infection † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Rhinitis † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Rickettsiosis † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Sepsis † 1  5/1515 (0.33%)  5 3/757 (0.40%)  3
Staphylococcal bacteraemia † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Staphylococcal infection † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Streptococcal bacteraemia † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Upper respiratory tract infection † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Urinary tract infection † 1  4/1515 (0.26%)  4 1/757 (0.13%)  1
Urinary tract infection bacterial † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Vestibular neuronitis † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Viral pericarditis † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Viral upper respiratory tract infection † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Injury, poisoning and procedural complications     
Accidental overdose † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Alcohol poisoning † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Clavicle fracture † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Fall † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Femoral neck fracture † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Femur fracture † 1  6/1515 (0.40%)  6 0/757 (0.00%)  0
Fibula fracture † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Fracture † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Hip fracture † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Humerus fracture † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Incision site pain † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Incisional hernia † 1  2/1515 (0.13%)  2 0/757 (0.00%)  0
Joint dislocation † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Multiple fractures † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Multiple injuries † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Post procedural haematoma † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Post procedural haemorrhage † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Postoperative thoracic procedure complication † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Procedural complication † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Procedural haemorrhage † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Procedural intestinal perforation † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Rib fracture † 1  3/1515 (0.20%)  3 1/757 (0.13%)  1
Road traffic accident † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Skull fracture † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Spinal compression fracture † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Spinal fracture † 1  2/1515 (0.13%)  2 0/757 (0.00%)  0
Splenic rupture † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Subdural haematoma † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Tendon rupture † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Thoracic vertebral fracture † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Tibia fracture † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Toxicity to various agents † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Traumatic intracranial haemorrhage † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Upper limb fracture † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Vascular graft occlusion † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Vascular pseudoaneurysm † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Wound † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Wrist fracture † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Investigations     
Alanine aminotransferase increased † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Aspartate aminotransferase increased † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Blood uric acid increased † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Gamma-glutamyltransferase increased † 1  3/1515 (0.20%)  3 0/757 (0.00%)  0
Hepatic enzyme increased † 1  1/1515 (0.07%)  1 2/757 (0.26%)  2
Liver function test abnormal † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Metabolism and nutrition disorders     
Dehydration † 1  2/1515 (0.13%)  2 1/757 (0.13%)  1
Diabetes mellitus † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Diabetes mellitus inadequate control † 1  2/1515 (0.13%)  2 0/757 (0.00%)  0
Diabetic ketoacidosis † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Failure to thrive † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Hyperglycaemia † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Hyperkalaemia † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Hypoglycaemia † 1  2/1515 (0.13%)  2 0/757 (0.00%)  0
Hyponatraemia † 1  2/1515 (0.13%)  3 0/757 (0.00%)  0
Insulin-requiring type 2 diabetes mellitus † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Metabolic alkalosis † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Metabolic disorder † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Arthritis † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Back pain † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Fibromyalgia † 1  0/1515 (0.00%)  0 1/757 (0.13%)  2
Intervertebral disc protrusion † 1  3/1515 (0.20%)  3 1/757 (0.13%)  1
Lumbar spinal stenosis † 1  4/1515 (0.26%)  4 1/757 (0.13%)  1
Musculoskeletal chest pain † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Musculoskeletal discomfort † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Musculoskeletal pain † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Osteoarthritis † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Osteonecrosis † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Pain in extremity † 1  3/1515 (0.20%)  3 0/757 (0.00%)  0
Rheumatoid arthritis † 1  0/1515 (0.00%)  0 2/757 (0.26%)  2
Spinal column stenosis † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Spinal osteoarthritis † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Systemic sclerosis † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Adenocarcinoma gastric † 1  4/1515 (0.26%)  4 0/757 (0.00%)  0
Adenocarcinoma of colon † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Adenocarcinoma pancreas † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Basal cell carcinoma † 1  8/1515 (0.53%)  8 4/757 (0.53%)  4
Benign oesophageal neoplasm † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Bladder cancer † 1  2/1515 (0.13%)  2 2/757 (0.26%)  2
Bladder transitional cell carcinoma † 1  2/1515 (0.13%)  2 0/757 (0.00%)  0
Bladder transitional cell carcinoma stage ii † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Bowen's disease † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Breast cancer † 1  1/1515 (0.07%)  1 2/757 (0.26%)  2
Brenner tumour † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Carcinoma in situ of skin † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Cerebral haemangioma † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Cholangiocarcinoma † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Clear cell renal cell carcinoma † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Colon cancer † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Dermatofibrosarcoma protuberans † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Diffuse large b-cell lymphoma † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Gastric cancer † 1  2/1515 (0.13%)  2 2/757 (0.26%)  2
Gastrointestinal stromal tumour † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Hepatic cancer † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Hepatocellular carcinoma † 1  2/1515 (0.13%)  4 0/757 (0.00%)  0
Intraductal proliferative breast lesion † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Invasive ductal breast carcinoma † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Laryngeal cancer † 1  0/1515 (0.00%)  0 2/757 (0.26%)  2
Laryngeal squamous cell carcinoma † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Lentigo maligna † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Leukaemia † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Malignant melanoma † 1  2/1515 (0.13%)  2 0/757 (0.00%)  0
Malignant peritoneal neoplasm † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Metastases to central nervous system † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Myelodysplastic syndrome † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Oesophageal adenocarcinoma † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Oropharyngeal cancer † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Ovarian cancer metastatic † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Ovarian fibroma † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Pancreatic carcinoma † 1  0/1515 (0.00%)  0 2/757 (0.26%)  2
Pancreatic carcinoma metastatic † 1  0/1515 (0.00%)  0 0/757 (0.00%)  0
Papillary thyroid cancer † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Prostate cancer † 1  8/1515 (0.53%)  8 2/757 (0.26%)  2
Prostate cancer recurrent † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Rectal adenocarcinoma † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Renal cancer † 1  3/1515 (0.20%)  3 0/757 (0.00%)  0
Seborrhoeic keratosis † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Small cell lung cancer † 1  2/1515 (0.13%)  2 1/757 (0.13%)  1
Squamous cell carcinoma † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Squamous cell carcinoma of pharynx † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Tracheal cancer † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Transitional cell carcinoma † 1  5/1515 (0.33%)  5 2/757 (0.26%)  2
Squamous cell carcinoma of skin † 1  4/1515 (0.26%)  4 4/757 (0.53%)  4
Nervous system disorders     
Presyncope † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Sciatica † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Subarachnoid haemorrhage † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Syncope † 1  4/1515 (0.26%)  4 2/757 (0.26%)  2
Transient global amnesia † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Transient ischaemic attack † 1  2/1515 (0.13%)  2 2/757 (0.26%)  2
Unresponsive to stimuli † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Brain injury † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Carotid artery stenosis † 1  2/1515 (0.13%)  2 0/757 (0.00%)  0
Cerebral haemorrhage † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Cerebral infarction † 1  2/1515 (0.13%)  2 2/757 (0.26%)  2
Cerebral ischaemia † 1  0/1515 (0.00%)  0 2/757 (0.26%)  2
Cerebrovascular accident † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Convulsion † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Dementia Alzheimer's type † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Dizziness † 1  3/1515 (0.20%)  3 0/757 (0.00%)  0
Epilepsy † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Headache † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Hemiparesis † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Intracranial aneurysm † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Ischaemic stroke † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Loss of consciousness † 1  2/1515 (0.13%)  2 0/757 (0.00%)  0
Psychiatric disorders     
Alcohol withdrawal syndrome † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Completed suicide † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Confusional state † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Delirium † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Depression † 1  2/1515 (0.13%)  2 0/757 (0.00%)  0
Mental status changes † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Renal and urinary disorders     
Glomerulonephritis rapidly progressive † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Haematuria † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Hydronephrosis † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Nephrolithiasis † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Renal cyst † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Renal failure acute † 1  5/1515 (0.33%)  5 2/757 (0.26%)  2
Ureteric dilatation † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Urethral stenosis † 1  2/1515 (0.13%)  2 0/757 (0.00%)  0
Urinary bladder polyp † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Reproductive system and breast disorders     
Acquired hydrocele † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Benign prostatic hyperplasia † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Cervical dysplasia † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Ovarian cyst † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Respiratory, thoracic and mediastinal disorders     
Bronchostenosis † 1  2/1515 (0.13%)  2 1/757 (0.13%)  1
Acute respiratory distress syndrome † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Acute respiratory failure † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Alveolitis † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Apnoea † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Aspiration † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Asthma † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Bronchopleural fistula † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Dyspnoea † 1  6/1515 (0.40%)  6 3/757 (0.40%)  3
Epistaxis † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Haemoptysis † 1  2/1515 (0.13%)  2 0/757 (0.00%)  0
Hiccups † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Hypoxia † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Idiopathic pulmonary fibrosis † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Interstitial lung disease † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Laryngeal oedema † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Lung infiltration † 1  2/1515 (0.13%)  2 0/757 (0.00%)  0
Pleural effusion † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Pleurisy † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Pneumonia aspiration † 1  3/1515 (0.20%)  3 1/757 (0.13%)  1
Pneumothorax † 1  4/1515 (0.26%)  4 3/757 (0.40%)  3
Pneumothorax spontaneous † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Pulmonary artery thrombosis † 1  1/1515 (0.07%)  2 0/757 (0.00%)  0
Pulmonary embolism † 1  7/1515 (0.46%)  7 4/757 (0.53%)  5
Pulmonary granuloma † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Pulmonary haemorrhage † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Pulmonary mass † 1  1/1515 (0.07%)  1 1/757 (0.13%)  1
Respiratory distress † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Respiratory failure † 1  0/1515 (0.00%)  0 3/757 (0.40%)  3
Sleep apnoea syndrome † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Chronic obstructive pulmonary disease † 1  17/1515 (1.12%)  18 4/757 (0.53%)  7
Skin and subcutaneous tissue disorders     
Angioedema † 1  0/1515 (0.00%)  0 1/757 (0.13%)  2
Eczema † 1  0/1515 (0.00%)  0 2/757 (0.26%)  2
Leukocytoclastic vasculitis † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Rash pruritic † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Vascular disorders     
Aortic aneurysm † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Aortic aneurysm rupture † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Bleeding varicose vein † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Circulatory collapse † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Deep vein thrombosis † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Haematoma † 1  1/1515 (0.07%)  2 0/757 (0.00%)  0
Hypertension † 1  3/1515 (0.20%)  3 0/757 (0.00%)  0
Hypotension † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Neurogenic shock † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Pelvic venous thrombosis † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Peripheral arterial occlusive disease † 1  2/1515 (0.13%)  2 5/757 (0.66%)  5
Peripheral artery thrombosis † 1  1/1515 (0.07%)  2 0/757 (0.00%)  0
Peripheral embolism † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
Peripheral ischaemia † 1  0/1515 (0.00%)  0 2/757 (0.26%)  2
Peripheral vascular disorder † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Superior vena cava syndrome † 1  1/1515 (0.07%)  1 0/757 (0.00%)  0
Thrombophlebitis † 1  0/1515 (0.00%)  0 1/757 (0.13%)  1
1
Term from vocabulary, MedDRA 16.1
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GSK1572932 Group Placebo Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1225/1515 (80.86%)      300/757 (39.63%)    
Gastrointestinal disorders     
Diarrhoea † 1  76/1515 (5.02%)  110 31/757 (4.10%)  42
Nausea † 1  108/1515 (7.13%)  177 36/757 (4.76%)  45
General disorders     
Asthenia † 1  92/1515 (6.07%)  199 26/757 (3.43%)  55
Chills † 1  118/1515 (7.79%)  249 7/757 (0.92%)  16
Fatigue † 1  243/1515 (16.04%)  579 50/757 (6.61%)  85
Influenza like illness † 1  198/1515 (13.07%)  682 23/757 (3.04%)  39
Injection site erythema † 1  104/1515 (6.86%)  344 3/757 (0.40%)  3
Injection site pain † 1  476/1515 (31.42%)  1880 35/757 (4.62%)  73
Injection site reaction † 1  273/1515 (18.02%)  1368 14/757 (1.85%)  17
Pain † 1  237/1515 (15.64%)  578 14/757 (1.85%)  26
Pyrexia † 1  529/1515 (34.92%)  1732 38/757 (5.02%)  49
Metabolism and nutrition disorders     
Decreased appetite † 1  79/1515 (5.21%)  112 28/757 (3.70%)  30
Musculoskeletal and connective tissue disorders     
Arthralgia † 1  105/1515 (6.93%)  161 31/757 (4.10%)  35
Myalgia † 1  183/1515 (12.08%)  588 20/757 (2.64%)  23
Pain in extremity † 1  125/1515 (8.25%)  251 24/757 (3.17%)  29
Nervous system disorders     
Headache † 1  129/1515 (8.51%)  241 40/757 (5.28%)  50
Respiratory, thoracic and mediastinal disorders     
Cough † 1  131/1515 (8.65%)  155 71/757 (9.38%)  80
Dyspnoea † 1  83/1515 (5.48%)  91 47/757 (6.21%)  52
Skin and subcutaneous tissue disorders     
Erythema † 1  120/1515 (7.92%)  258 6/757 (0.79%)  6
1
Term from vocabulary, MedDRA 16.1
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00480025    
Obsolete Identifiers: NCT00638105
Other Study ID Numbers: 109493
2007-001283-73 ( EudraCT Number )
First Submitted: May 29, 2007
First Posted: May 30, 2007
Results First Submitted: December 5, 2016
Results First Posted: January 30, 2019
Last Update Posted: December 22, 2020