Trial Outcomes & Findings for GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer (NCT NCT00480025)
NCT ID: NCT00480025
Last Updated: 2020-12-22
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
2278 participants
Primary outcome timeframe
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)
Results posted on
2020-12-22
Participant Flow
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.
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).
Participant milestones
| Measure |
GSK1572932 Group
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
Placebo Group
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
1515
|
757
|
|
Overall Study
COMPLETED
|
763
|
388
|
|
Overall Study
NOT COMPLETED
|
752
|
369
|
Reasons for withdrawal
| Measure |
GSK1572932 Group
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
Placebo Group
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
12
|
7
|
|
Overall Study
Patients remaining ongoing at Data Lock
|
101
|
55
|
|
Overall Study
Disease Progression / Recurrence
|
449
|
224
|
|
Overall Study
Adverse Event
|
44
|
12
|
|
Overall Study
Other
|
70
|
29
|
|
Overall Study
SAE including intercurrent illness
|
76
|
42
|
Baseline Characteristics
GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
GSK1572932 Group
n=1515 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
Placebo Group
n=757 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
Total
n=2272 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.1 Years
STANDARD_DEVIATION 8.96 • n=5 Participants
|
63.4 Years
STANDARD_DEVIATION 9.15 • n=7 Participants
|
63.2 Years
STANDARD_DEVIATION 9.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
370 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
549 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1145 Participants
n=5 Participants
|
578 Participants
n=7 Participants
|
1723 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · African heritage/African American
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - Central/South Asian heritage
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - East Asian heritage
|
195 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
307 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - Japanese heritage
|
138 Participants
n=5 Participants
|
71 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - South East Asian heritage
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Native Hawaiian or other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · White - Arabic//North African heritage
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · White - Caucasian/European heritage
|
1129 Participants
n=5 Participants
|
539 Participants
n=7 Participants
|
1668 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Other
|
11 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Missing confirmed
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=1515 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=757 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the Overall Population
|
0.17 events/person-years
|
0.168 events/person-years
|
PRIMARY outcome
Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=731 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=365 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the No-CT Population
|
0.169 events/person-years
|
0.178 events/person-years
|
SECONDARY outcome
Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=784 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=392 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the CT Population
|
0.172 events/person-years
|
0.158 events/person-years
|
SECONDARY outcome
Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=1515 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=757 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Person Year Rate (PYAR) as Regards Overall-survival (OS) in the Overall Population
|
0.082 events/person-years
|
0.081 events/person-years
|
SECONDARY outcome
Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=731 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=365 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Person Year Rate (PYAR) as Regards Overall-survival (OS) in the No-CT Population
|
0.084 events/person-years
|
0.086 events/person-years
|
SECONDARY outcome
Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=784 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=392 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Person Year Rate (PYAR) as Regards Overall-survival (OS) in the CT Population
|
0.08 events/person-years
|
0.076 events/person-years
|
SECONDARY outcome
Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=1515 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=757 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the Overall Population
|
0.064 events/person-years
|
0.061 events/person-years
|
SECONDARY outcome
Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=731 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=365 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the No-CT Population
|
0.064 events/person-years
|
0.06 events/person-years
|
SECONDARY outcome
Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=784 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=392 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the CT Population
|
0.063 events/person-years
|
0.063 events/person-years
|
SECONDARY outcome
Timeframe: KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment. Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=1515 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=757 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the Overall Population
DFS KME at 2Y - Overall Population
|
65.57 percent probability
Interval 63.08 to 67.95
|
65.5 percent probability
Interval 61.94 to 68.81
|
|
Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the Overall Population
DFS KME at 3Y - Overall Population
|
59.97 percent probability
Interval 57.3 to 62.53
|
60.42 percent probability
Interval 56.62 to 64.0
|
|
Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the Overall Population
DFS KME at 4Y - Overall Population
|
56.72 percent probability
Interval 53.8 to 59.54
|
57.19 percent probability
Interval 53.07 to 61.1
|
|
Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the Overall Population
DFS KME at 5Y - Overall Population
|
51.73 percent probability
Interval 47.66 to 55.64
|
49.56 percent probability
Interval 42.87 to 55.88
|
SECONDARY outcome
Timeframe: KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=731 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=365 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the No-CT Population
DFS KME at 2Y - No-CT Population
|
66.03 percent probability
Interval 62.39 to 69.4
|
63.96 percent probability
Interval 58.72 to 68.72
|
|
Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the No-CT Population
DFS KME at 3Y - No-CT Population
|
59.6 percent probability
Interval 55.7 to 63.27
|
57.62 percent probability
Interval 52.02 to 62.81
|
|
Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the No-CT Population
DFS KME at 4Y - No-CT Population
|
55.4 percent probability
Interval 51.06 to 59.52
|
54.85 percent probability
Interval 48.98 to 60.33
|
|
Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the No-CT Population
DFS KME at 5Y - No-CT Population
|
49.72 percent probability
Interval 43.44 to 55.67
|
44.59 percent probability
Interval 34.64 to 54.05
|
SECONDARY outcome
Timeframe: KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment. Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=784 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=392 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the CT Population
DFS KME at 2Y - CT Population
|
65.17 percent probability
Interval 61.67 to 68.43
|
66.94 percent probability
Interval 61.98 to 71.41
|
|
Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the CT Population
DFS KME at 3Y - CT Population
|
60.39 percent probability
Interval 56.68 to 63.89
|
63.09 percent probability
Interval 57.84 to 67.87
|
|
Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the CT Population
DFS KME at 4Y - CT Population
|
58.17 percent probability
Interval 54.22 to 61.9
|
59.3 percent probability
Interval 53.33 to 64.76
|
|
Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the CT Population
DFS KME at 5Y - CT Population
|
53.64 percent probability
Interval 48.28 to 58.7
|
54.8 percent probability
Interval 46.44 to 62.39
|
SECONDARY outcome
Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=1515 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=757 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the Overall Population
|
0.159 events/person-years
|
0.154 events/person-years
|
SECONDARY outcome
Timeframe: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=731 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=365 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the No-CT Population
|
0.155 events/person-years
|
0.159 events/person-years
|
SECONDARY outcome
Timeframe: Period of follow-up was from administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=784 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=392 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the CT Population
|
0.162 events/person-years
|
0.149 events/person-years
|
SECONDARY outcome
Timeframe: Pre-treatment (PRE), at Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (At 12M post W120)Population: The According-To-Protocol (ATP) population for immunogenicity including all evaluable patients (meeting all eligibility criteria, complying with protocol defined procedures and intervals, with no elimination criteria during the study) who received at least the 4 first doses and for whom data were available for the considered assay and time point.
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).
Outcome measures
| Measure |
GSK1572932 Group
n=1184 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=614 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+)
Anti-MAGE-A3 S+, PRE
|
105 Participants
|
53 Participants
|
|
Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+)
Anti-MAGE-A3 S+, W6
|
929 Participants
|
43 Participants
|
|
Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+)
Anti-MAGE-A3 S+, W12
|
921 Participants
|
42 Participants
|
|
Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+)
Anti-MAGE-A3 S+, M9
|
631 Participants
|
30 Participants
|
|
Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+)
Anti-MAGE-A3 S+, M12
|
536 Participants
|
19 Participants
|
|
Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+)
Anti-MAGE-A3 S+, M18
|
419 Participants
|
15 Participants
|
|
Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+)
Anti-MAGE-A3 S+, M30
|
383 Participants
|
17 Participants
|
|
Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+)
Anti-MAGE-A3 S+, at 12M post W120
|
75 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: At Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)Population: The According-To-Protocol (ATP) population for immunogenicity including all evaluable patients (meeting all eligibility criteria, complying with protocol defined procedures and intervals, with no elimination criteria during the study) who received at least the 4 first doses and for whom data were available for the considered assay and time point.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=942 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=548 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR)
Anti-MAGE-A3 HR, W6
|
922 Participants
|
10 Participants
|
|
Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR)
Anti-MAGE-A3 HR, W12
|
916 Participants
|
15 Participants
|
|
Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR)
Anti-MAGE-A3 HR, M9
|
627 Participants
|
13 Participants
|
|
Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR)
Anti-MAGE-A3 HR, M12
|
534 Participants
|
6 Participants
|
|
Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR)
Anti-MAGE-A3 HR, M18
|
417 Participants
|
7 Participants
|
|
Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR)
Anti-MAGE-A3 HR, M30
|
380 Participants
|
8 Participants
|
|
Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR)
Anti-MAGE-A3 HR, at 12M post W120
|
75 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Pre-treatment (PRE), at Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)Population: The According-To-Protocol (ATP) population for immunogenicity including all evaluable patients (meeting all eligibility criteria, complying with protocol defined procedures and intervals, with no elimination criteria during the study) who received at least the 4 first doses and for whom data were available for the considered assay and time point.
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).
Outcome measures
| Measure |
GSK1572932 Group
n=1096 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=554 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+)
Anti-PD S+, PRE
|
381 Participants
|
210 Participants
|
|
Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+)
Anti-PD S+, W6
|
958 Participants
|
195 Participants
|
|
Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+)
Anti-PD S+, W12
|
860 Participants
|
176 Participants
|
|
Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+)
Anti-PD S+, M9
|
580 Participants
|
133 Participants
|
|
Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+)
Anti-PD S+, M12
|
483 Participants
|
101 Participants
|
|
Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+)
Anti-PD S+, M18
|
375 Participants
|
77 Participants
|
|
Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+)
Anti-PD S+, M30
|
357 Participants
|
75 Participants
|
|
Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+)
Anti-PD S+, at 12M post W120
|
77 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: At Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)Population: The According-To-Protocol (ATP) population for immunogenicity including all evaluable patients (meeting all eligibility criteria, complying with protocol defined procedures and intervals, with no elimination criteria during the study) who received at least the 4 first doses and for whom data were available for the considered assay and time point.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=962 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=490 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR)
Anti-PD HR, W6
|
945 Participants
|
27 Participants
|
|
Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR)
Anti-PD HR, W12
|
853 Participants
|
35 Participants
|
|
Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR)
Anti-PD HR, M9
|
575 Participants
|
26 Participants
|
|
Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR)
Anti-PD HR, M12
|
479 Participants
|
19 Participants
|
|
Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR)
Anti-PD HR, M18
|
370 Participants
|
21 Participants
|
|
Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR)
Anti-PD HR, M30
|
352 Participants
|
17 Participants
|
|
Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR)
Anti-PD HR, at 12M post W120
|
77 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 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 W120Population: The Total Treated population - as randomized included patients in the treatment group as allocated by the randomization system at the start of the study.
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).
Outcome measures
| Measure |
GSK1572932 Group
n=226 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=103 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Health-related Quality of Life (HQL) Scores
EQ-5D UV, At W12 DoT
|
0.848 Scores on a scale
Standard Deviation 0.158
|
0.811 Scores on a scale
Standard Deviation 0.236
|
|
Health-related Quality of Life (HQL) Scores
EQ-5D UV, At W12 DpT
|
0.841 Scores on a scale
Standard Deviation 0.152
|
0.831 Scores on a scale
Standard Deviation 0.211
|
|
Health-related Quality of Life (HQL) Scores
EQ-5D UV, At W0 DoT
|
0.83 Scores on a scale
Standard Deviation 0.152
|
0.823 Scores on a scale
Standard Deviation 0.189
|
|
Health-related Quality of Life (HQL) Scores
EQ-5D UV, At W0 DpT
|
0.788 Scores on a scale
Standard Deviation 0.182
|
0.838 Scores on a scale
Standard Deviation 0.177
|
|
Health-related Quality of Life (HQL) Scores
EQ-5D UV, At W6 DoT
|
0.837 Scores on a scale
Standard Deviation 0.182
|
0.825 Scores on a scale
Standard Deviation 0.191
|
|
Health-related Quality of Life (HQL) Scores
EQ-5D UV, At W6 DpT
|
0.798 Scores on a scale
Standard Deviation 0.205
|
0.835 Scores on a scale
Standard Deviation 0.176
|
|
Health-related Quality of Life (HQL) Scores
EQ-5D UV, At M6
|
0.847 Scores on a scale
Standard Deviation 0.182
|
0.825 Scores on a scale
Standard Deviation 0.236
|
|
Health-related Quality of Life (HQL) Scores
EQ-5D UV, At M9
|
0.84 Scores on a scale
Standard Deviation 0.197
|
0.81 Scores on a scale
Standard Deviation 0.219
|
|
Health-related Quality of Life (HQL) Scores
EQ-5D UV, At M12
|
0.857 Scores on a scale
Standard Deviation 0.166
|
0.824 Scores on a scale
Standard Deviation 0.214
|
|
Health-related Quality of Life (HQL) Scores
EQ-5D UV, At M24
|
0.855 Scores on a scale
Standard Deviation 0.179
|
0.865 Scores on a scale
Standard Deviation 0.145
|
|
Health-related Quality of Life (HQL) Scores
EQ-5D UV, At 6M post W120
|
0.723 Scores on a scale
Standard Deviation 0.298
|
0.679 Scores on a scale
Standard Deviation 0.073
|
|
Health-related Quality of Life (HQL) Scores
EQ-5D UV, At recurrence
|
0.662 Scores on a scale
Standard Deviation 0.343
|
0.785 Scores on a scale
Standard Deviation 0.159
|
|
Health-related Quality of Life (HQL) Scores
EQ-5D UV, At 12M post W120
|
0.753 Scores on a scale
Standard Deviation 0.199
|
0.777 Scores on a scale
Standard Deviation 0.395
|
SECONDARY outcome
Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=1515 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=757 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR UNK; DLP G0
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR UNK; DLP G1
|
1 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR UNK; DLP G2
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR UNK; DLP G3
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR UNK; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR UNK; DLP UNK
|
3 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G0; DLP G0
|
1133 Participants
|
588 Participants
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G0; DLP G1
|
162 Participants
|
77 Participants
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G0; DLP G2
|
17 Participants
|
8 Participants
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G0; DLP G3
|
7 Participants
|
7 Participants
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G0; DLP G4
|
1 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G0; DLP UNK
|
113 Participants
|
37 Participants
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G1; DLP G0
|
34 Participants
|
14 Participants
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G1; DLP G1
|
32 Participants
|
17 Participants
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G1; DLP G2
|
4 Participants
|
3 Participants
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G1; DLP G3
|
1 Participants
|
2 Participants
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G1; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G1; DLP UNK
|
4 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G2; DLP G0
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G2; DLP G1
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G2; DLP G2
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G2; DLP G3
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G2; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade
ALT - SCR G2; DLP UNK
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=1515 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=757 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR UNK; DLP G0
|
12 Participants
|
4 Participants
|
|
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR UNK; DLP G1
|
5 Participants
|
2 Participants
|
|
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR UNK; DLP G2
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR UNK; DLP G3
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR UNK; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR UNK; DLP UNK
|
5 Participants
|
2 Participants
|
|
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G0; DLP G0
|
1170 Participants
|
579 Participants
|
|
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G0; DLP G1
|
136 Participants
|
84 Participants
|
|
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G0; DLP G2
|
6 Participants
|
4 Participants
|
|
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G0; DLP G3
|
8 Participants
|
5 Participants
|
|
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G0; DLP G4
|
2 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G0; DLP UNK
|
111 Participants
|
37 Participants
|
|
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G1; DLP G0
|
26 Participants
|
19 Participants
|
|
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G1; DLP G1
|
25 Participants
|
16 Participants
|
|
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G1; DLP G2
|
5 Participants
|
2 Participants
|
|
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G1; DLP G3
|
0 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G1; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G1; DLP UNK
|
2 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G2; DLP G0
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G2; DLP G1
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G2; DLP G2
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G2; DLP G3
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G2; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade
AST - SCR G2; DLP UNK
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=1515 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=757 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
ALKP - SCR UNK; DLP G0
|
21 Participants
|
3 Participants
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
ALKP - SCR UNK; DLP G1
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
ALKP - SCR UNK; DLP G2
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
ALKP - SCR UNK; DLP G3
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
ALKP - SCR UNK; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
ALKP - SCR UNK; DLP UNK
|
5 Participants
|
3 Participants
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
ALKP - SCR G0; DLP G0
|
1121 Participants
|
569 Participants
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
ALKP - SCR G0; DLP G1
|
99 Participants
|
63 Participants
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
ALKP - SCR G0; DLP G2
|
3 Participants
|
2 Participants
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
ALKP - SCR G0; DLP G3
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
ALKP - SCR G0; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
ALKP - SCR G0; DLP UNK
|
107 Participants
|
39 Participants
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
ALKP - SCR G1; DLP G0
|
63 Participants
|
35 Participants
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
ALKP - SCR G1; DLP G1
|
79 Participants
|
38 Participants
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
ALKP - SCR G1; DLP G2
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
ALKP - SCR G1; DLP G3
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
ALKP - SCR G1; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
ALKP - SCR G1; DLP UNK
|
11 Participants
|
4 Participants
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
ALKP - SCR G2; DLP G0
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
ALKP - SCR G2; DLP G1
|
2 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
ALKP - SCR G2; DLP G2
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
ALKP - SCR G2; DLP G3
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
ALKP - SCR G2; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade
ALKP - SCR G2; DLP UNK
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=1515 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=757 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade
BIL - SCR UNK; DLP G3
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade
BIL - SCR UNK; DLP G0
|
9 Participants
|
2 Participants
|
|
Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade
BIL - SCR UNK; DLP G1
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade
BIL - SCR UNK; DLP G2
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade
BIL - SCR UNK; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade
BIL - SCR UNK; DLP UNK
|
4 Participants
|
2 Participants
|
|
Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade
BIL - SCR G0; DLP G0
|
1275 Participants
|
661 Participants
|
|
Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade
BIL - SCR G0; DLP G1
|
74 Participants
|
28 Participants
|
|
Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade
BIL - SCR G0; DLP G2
|
11 Participants
|
9 Participants
|
|
Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade
BIL - SCR G0; DLP G3
|
1 Participants
|
2 Participants
|
|
Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade
BIL - SCR G0; DLP G4
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade
BIL - SCR G0; DLP UNK
|
114 Participants
|
37 Participants
|
|
Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade
BIL - SCR G1; DLP G0
|
10 Participants
|
5 Participants
|
|
Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade
BIL - SCR G1; DLP G1
|
8 Participants
|
9 Participants
|
|
Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade
BIL - SCR G1; DLP G2
|
5 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade
BIL - SCR G1; DLP G3
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade
BIL - SCR G1; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade
BIL - SCR G1; DLP UNK
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=1515 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=757 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR UNK; DLP G0
|
2 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR UNK; DLP G1
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR UNK; DLP G2
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR UNK; DLP G3
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR UNK; DLP G4
|
2 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR UNK; DLP UNK
|
1139 Participants
|
577 Participants
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G0; DLP G0
|
126 Participants
|
74 Participants
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G0; DLP G1
|
9 Participants
|
3 Participants
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G0; DLP G2
|
3 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G0; DLP G3
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G0; DLP G4
|
103 Participants
|
32 Participants
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G0; DLP UNK
|
27 Participants
|
14 Participants
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G1; DLP G0
|
72 Participants
|
44 Participants
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G1; DLP G1
|
11 Participants
|
6 Participants
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G1; DLP G2
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G1; DLP G3
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G1; DLP G4
|
6 Participants
|
4 Participants
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G1; DLP UNK
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G2; DLP G0
|
7 Participants
|
2 Participants
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G2; DLP G1
|
6 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G2; DLP G2
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G2; DLP G3
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G2; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade
CREA - SCR G2; DLP UNK
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=1515 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=757 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR G1; DLP G4
|
2 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR UNK; DLP G0
|
3 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR UNK; DLP G1
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR UNK; DLP G2
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR UNK; DLP G3
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR UNK; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR UNK; DLP UNK
|
3 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR G0; DLP G0
|
534 Participants
|
274 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR G0; DLP G1
|
70 Participants
|
26 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR G0; DLP G2
|
9 Participants
|
5 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR G0; DLP G3
|
1 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR G0; DLP G4
|
0 Participants
|
2 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR G0; DLP UNK
|
50 Participants
|
19 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR G1; DLP G0
|
342 Participants
|
187 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR G1; DLP G1
|
310 Participants
|
142 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR G1; DLP G2
|
17 Participants
|
14 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR G1; DLP G3
|
6 Participants
|
3 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR G1; DLP UNK
|
49 Participants
|
15 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR G2; DLP G0
|
29 Participants
|
30 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR G2; DLP G1
|
63 Participants
|
31 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR G2; DLP G2
|
12 Participants
|
3 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR G2; DLP G3
|
1 Participants
|
3 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR G2; DLP G4
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR G2; DLP UNK
|
6 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR G3; DLP G0
|
2 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR G3; DLP G1
|
3 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR G3; DLP G2
|
1 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR G3; DLP G3
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR G3; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade
HGB - SCR G3; DLP UNK
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=1515 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=757 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR UNK; DLP G0
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR UNK; DLP G1
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR UNK; DLP G2
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR UNK; DLP G3
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR UNK; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR UNK; DLP UNK
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G0; DLP G0
|
1259 Participants
|
652 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G0; DLP G1
|
45 Participants
|
29 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G0; DLP G2
|
4 Participants
|
2 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G0; DLP G3
|
2 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G0; DLP G4
|
6 Participants
|
2 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G0; DLP UNK
|
98 Participants
|
32 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G1; DLP G0
|
54 Participants
|
24 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G1; DLP G1
|
21 Participants
|
5 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G1; DLP G2
|
2 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G1; DLP G3
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G1; DLP G4
|
0 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G1; DLP UNK
|
4 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G2; DLP G0
|
13 Participants
|
6 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G2; DLP G1
|
3 Participants
|
2 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G2; DLP G2
|
2 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G2; DLP G3
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G2; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G2; DLP UNK
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G3; DLP G0
|
0 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G3; DLP G1
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G3; DLP G2
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G3; DLP G3
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G3; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade
LEU - SCR G3; DLP UNK
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=1515 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=757 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR UNK; DLP G0
|
12 Participants
|
3 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR UNK; DLP G1
|
3 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR UNK; DLP G2
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR UNK; DLP G3
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR UNK; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR UNK; DLP UNK
|
4 Participants
|
2 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR G0; DLP G0
|
999 Participants
|
518 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR G0; DLP G1
|
160 Participants
|
89 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR G0; DLP G2
|
40 Participants
|
16 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR G0; DLP G3
|
5 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR G0; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR G0; DLP UNK
|
96 Participants
|
35 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR G1; DLP G0
|
47 Participants
|
27 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR G1; DLP G1
|
86 Participants
|
42 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR G1; DLP G2
|
15 Participants
|
4 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR G1; DLP G3
|
1 Participants
|
4 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR G1; DLP G4
|
2 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR G1; DLP UNK
|
20 Participants
|
5 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR G2; DLP G0
|
3 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR G2; DLP G1
|
7 Participants
|
2 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR G2; DLP G2
|
4 Participants
|
3 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR G2; DLP G3
|
2 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR G2; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR G2; DLP UNK
|
0 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR G3; DLP G0
|
4 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR G3; DLP G1
|
1 Participants
|
2 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR G3; DLP G2
|
3 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR G3; DLP G3
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR G3; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade
LYM - SCR G3; DLP UNK
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=1515 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=757 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR UNK; DLP G0
|
12 Participants
|
3 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR UNK; DLP G1
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR UNK; DLP G2
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR UNK; DLP G3
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR UNK; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR UNK; DLP UNK
|
1 Participants
|
2 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G0; DLP G0
|
1200 Participants
|
625 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G0; DLP G1
|
47 Participants
|
28 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G0; DLP G2
|
1 Participants
|
3 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G0; DLP G3
|
2 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G0; DLP G4
|
3 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G0; DLP UNK
|
111 Participants
|
37 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G1; DLP G0
|
56 Participants
|
23 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G1; DLP G1
|
31 Participants
|
10 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G1; DLP G2
|
3 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G1; DLP G3
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G1; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G1; DLP UNK
|
3 Participants
|
2 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G2; DLP G0
|
32 Participants
|
16 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G2; DLP G1
|
5 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G2; DLP G2
|
2 Participants
|
2 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G2; DLP G3
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G2; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G2; DLP UNK
|
1 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G3; DLP G0
|
3 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G3; DLP G1
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G3; DLP G2
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G3; DLP G3
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G3; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G3; DLP UNK
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G4; DLP G0
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G4; DLP G1
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G4; DLP G2
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G4; DLP G3
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G4; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade
NEU - SCR G4; DLP UNK
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=1515 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=757 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
PLA - SCR UNK; DLP G0
|
1 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
PLA - SCR UNK; DLP G1
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
PLA - SCR UNK; DLP G2
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
PLA - SCR UNK; DLP G3
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
PLA - SCR UNK; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
PLA - SCR UNK; DLP UNK
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
PLA - SCR G0; DLP G0
|
1275 Participants
|
648 Participants
|
|
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
PLA - SCR G0; DLP G1
|
78 Participants
|
38 Participants
|
|
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
PLA - SCR G0; DLP G2
|
6 Participants
|
2 Participants
|
|
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
PLA - SCR G0; DLP G3
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
PLA - SCR G0; DLP G4
|
7 Participants
|
2 Participants
|
|
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
PLA - SCR G0; DLP UNK
|
98 Participants
|
35 Participants
|
|
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
PLA - SCR G1; DLP G0
|
22 Participants
|
16 Participants
|
|
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
PLA - SCR G1; DLP G1
|
17 Participants
|
10 Participants
|
|
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
PLA - SCR G1; DLP G2
|
2 Participants
|
4 Participants
|
|
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
PLA - SCR G1; DLP G3
|
1 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
PLA - SCR G1; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
PLA - SCR G1; DLP UNK
|
5 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
PLA - SCR G3; DLP G0
|
1 Participants
|
1 Participants
|
|
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
PLA - SCR G3; DLP G1
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
PLA - SCR G3; DLP G2
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
PLA - SCR G3; DLP G3
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
PLA - SCR G3; DLP G4
|
0 Participants
|
0 Participants
|
|
Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade
PLA - SCR G3; DLP UNK
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within the 31-day follow-up period post treatment administration, up to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=1515 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=757 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP)
Patients with G5 AEs
|
13 Participants
|
8 Participants
|
|
Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP)
Patients with any AEs
|
1369 Participants
|
556 Participants
|
|
Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP)
Patients with G1 AEs
|
563 Participants
|
225 Participants
|
|
Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP)
Patients with G2 AEs
|
560 Participants
|
209 Participants
|
|
Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP)
Patients with G3 AEs
|
184 Participants
|
88 Participants
|
|
Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP)
Patients with G4 AEs
|
49 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: From screening (SCR) up to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)Population: The Total Treated population - as treated included patients in the treatment group as per treatment actually received.
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.
Outcome measures
| Measure |
GSK1572932 Group
n=1515 Participants
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks
|
Placebo Group
n=757 Participants
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Number of Patients With Serious Adverse Events (SAEs) - Up to Data Lock Point (DLP)
|
330 Participants
|
164 Participants
|
Adverse Events
GSK1572932 Group
Serious events: 330 serious events
Other events: 1225 other events
Deaths: 30 deaths
Placebo Group
Serious events: 164 serious events
Other events: 300 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
GSK1572932 Group
n=1515 participants at risk
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
Placebo Group
n=757 participants at risk
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Vascular disorders
Aortic aneurysm
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Vascular disorders
Bleeding varicose vein
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Vascular disorders
Deep vein thrombosis
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Vascular disorders
Haematoma
|
0.07%
1/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Vascular disorders
Hypertension
|
0.20%
3/1515 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Vascular disorders
Hypotension
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Vascular disorders
Neurogenic shock
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.66%
5/757 • Number of events 5 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Vascular disorders
Peripheral artery thrombosis
|
0.07%
1/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.26%
2/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.26%
4/1515 • Number of events 4 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.53%
8/1515 • Number of events 8 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.53%
4/757 • Number of events 4 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign oesophageal neoplasm
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.26%
2/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma stage ii
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.26%
2/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brenner tumour
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma in situ of skin
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebral haemangioma
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dermatofibrosarcoma protuberans
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large b-cell lymphoma
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.26%
2/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.13%
2/1515 • Number of events 4 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.26%
2/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal squamous cell carcinoma
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant peritoneal neoplasm
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal adenocarcinoma
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oropharyngeal cancer
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer metastatic
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian fibroma
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.26%
2/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.53%
8/1515 • Number of events 8 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.26%
2/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cancer
|
0.20%
3/1515 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of pharynx
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tracheal cancer
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.33%
5/1515 • Number of events 5 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.26%
2/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.26%
4/1515 • Number of events 4 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.53%
4/757 • Number of events 4 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Immune system disorders
Hypersensitivity
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Immune system disorders
Immune system disorder
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
General disorders
Asthenia
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
General disorders
Chest discomfort
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.26%
2/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
General disorders
Chest pain
|
0.20%
3/1515 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.40%
3/757 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
General disorders
Death
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.40%
3/757 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
General disorders
Euthanasia
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
General disorders
Fatigue
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
General disorders
General physical health deterioration
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.26%
2/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
General disorders
Impaired healing
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
General disorders
Influenza like illness
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
General disorders
Mass
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
General disorders
Multi-organ failure
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
General disorders
Non-cardiac chest pain
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
General disorders
Pyrexia
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
General disorders
Sudden death
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Psychiatric disorders
Completed suicide
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Psychiatric disorders
Confusional state
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Psychiatric disorders
Depression
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Psychiatric disorders
Mental status changes
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Reproductive system and breast disorders
Acquired hydrocele
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Alcohol poisoning
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Fall
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.40%
6/1515 • Number of events 6 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Multiple injuries
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Procedural complication
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Procedural intestinal perforation
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.20%
3/1515 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Splenic rupture
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Investigations
Alanine aminotransferase increased
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Investigations
Aspartate aminotransferase increased
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Investigations
Blood uric acid increased
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.20%
3/1515 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Investigations
Hepatic enzyme increased
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.26%
2/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.26%
2/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Adams-stokes syndrome
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Angina pectoris
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Angina unstable
|
0.20%
3/1515 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.40%
3/757 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Atrial fibrillation
|
0.26%
4/1515 • Number of events 4 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.40%
3/757 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Atrial flutter
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Atrioventricular block
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Cardiac arrest
|
0.13%
2/1515 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Cardiac failure
|
0.33%
5/1515 • Number of events 6 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.40%
3/757 • Number of events 4 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Cardiac fibrillation
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Cardiac flutter
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Congestive cardiomyopathy
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Coronary artery disease
|
0.20%
3/1515 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Hypertensive heart disease
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Left ventricular failure
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Myocardial infarction
|
0.26%
4/1515 • Number of events 6 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.40%
3/757 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Pericardial effusion
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Prinzmetal angina
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Silent myocardial infarction
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Sinus bradycardia
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.40%
6/1515 • Number of events 6 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.40%
3/757 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.20%
3/1515 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.26%
4/1515 • Number of events 4 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.40%
3/757 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.07%
1/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.46%
7/1515 • Number of events 7 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.53%
4/757 • Number of events 5 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary granuloma
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.40%
3/757 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.1%
17/1515 • Number of events 18 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.53%
4/757 • Number of events 7 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.46%
7/1515 • Number of events 8 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.26%
2/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Blood and lymphatic system disorders
Anaemia macrocytic
|
0.07%
1/1515 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Blood and lymphatic system disorders
Hypersplenism
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Nervous system disorders
Presyncope
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Nervous system disorders
Sciatica
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Nervous system disorders
Syncope
|
0.26%
4/1515 • Number of events 4 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.26%
2/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Nervous system disorders
Transient global amnesia
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.26%
2/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Eye disorders
Age-related macular degeneration
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Eye disorders
Macular fibrosis
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Eye disorders
Retinal artery occlusion
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Ascites
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Colitis microscopic
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Constipation
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Diaphragmatic hernia
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Diverticulitis intestinal haemorrhagic
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.07%
1/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.26%
2/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Gastritis
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.33%
5/1515 • Number of events 5 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.46%
7/1515 • Number of events 7 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.26%
2/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Inguinal hernia, obstructive
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.07%
1/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Intestinal polyp
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Melaena
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Oesophagitis ulcerative
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Pancreatic necrosis
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Pancreatitis chronic
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Peritoneal adhesions
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Vomiting
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Renal and urinary disorders
Glomerulonephritis rapidly progressive
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Renal and urinary disorders
Haematuria
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Renal and urinary disorders
Renal failure acute
|
0.33%
5/1515 • Number of events 5 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.26%
2/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Renal and urinary disorders
Ureteric dilatation
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Renal and urinary disorders
Urethral stenosis
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Hepatobiliary disorders
Cholangitis
|
0.07%
1/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Hepatobiliary disorders
Cholangitis chronic
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.20%
3/1515 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.26%
2/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.26%
4/1515 • Number of events 4 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.26%
2/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Skin and subcutaneous tissue disorders
Leukocytoclastic vasculitis
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.20%
3/1515 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.26%
4/1515 • Number of events 4 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.20%
3/1515 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.26%
2/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Musculoskeletal and connective tissue disorders
Systemic sclerosis
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Endocrine disorders
Autoimmune thyroiditis
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Endocrine disorders
Hypothyroidism
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.13%
2/1515 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Metabolism and nutrition disorders
Insulin-requiring type 2 diabetes mellitus
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Metabolism and nutrition disorders
Metabolic alkalosis
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Metabolism and nutrition disorders
Metabolic disorder
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Abscess
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Acute hepatitis b
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Anal abscess
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Appendicitis
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Appendicitis perforated
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Bronchiolitis
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Bronchitis
|
0.20%
3/1515 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Bronchopneumonia
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.20%
3/1515 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Carbuncle
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Cellulitis
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Cellulitis streptococcal
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Chest wall abscess
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Citrobacter infection
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Device related infection
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Diverticulitis
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Enterocolitis infectious
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Gastroenteritis
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.26%
2/757 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Hepatitis b
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Herpes zoster
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Infectious pleural effusion
|
0.20%
3/1515 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways diseas
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Lobar pneumonia
|
0.33%
5/1515 • Number of events 5 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Lung infection
|
0.26%
4/1515 • Number of events 4 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Peritonitis
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Pneumonia
|
1.7%
26/1515 • Number of events 27 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
2.0%
15/757 • Number of events 16 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Pneumonia bacterial
|
0.26%
4/1515 • Number of events 4 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.53%
4/757 • Number of events 4 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Pneumonia pseudomonas aeruginosa
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Post procedural infection
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Q fever
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Renal abscess
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Respiratory tract infection
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Rhinitis
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Rickettsiosis
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Sepsis
|
0.33%
5/1515 • Number of events 5 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.40%
3/757 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Staphylococcal infection
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Urinary tract infection
|
0.26%
4/1515 • Number of events 4 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Vestibular neuronitis
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Viral pericarditis
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Blood and lymphatic system disorders
Hypochromic anaemia
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Nervous system disorders
Brain injury
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Nervous system disorders
Carotid artery stenosis
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Nervous system disorders
Cerebral infarction
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.26%
2/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.26%
2/757 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Nervous system disorders
Dementia Alzheimer's type
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Nervous system disorders
Dizziness
|
0.20%
3/1515 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Nervous system disorders
Epilepsy
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Nervous system disorders
Headache
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Nervous system disorders
Intracranial aneurysm
|
0.00%
0/1515 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.13%
1/757 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Nervous system disorders
Ischaemic stroke
|
0.07%
1/1515 • Number of events 1 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Nervous system disorders
Loss of consciousness
|
0.13%
2/1515 • Number of events 2 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.00%
0/757 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
Other adverse events
| Measure |
GSK1572932 Group
n=1515 participants at risk
Patients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
Placebo Group
n=757 participants at risk
Patients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
6.9%
105/1515 • Number of events 161 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
4.1%
31/757 • Number of events 35 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
General disorders
Asthenia
|
6.1%
92/1515 • Number of events 199 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
3.4%
26/757 • Number of events 55 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
General disorders
Chills
|
7.8%
118/1515 • Number of events 249 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.92%
7/757 • Number of events 16 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.6%
131/1515 • Number of events 155 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
9.4%
71/757 • Number of events 80 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.2%
79/1515 • Number of events 112 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
3.7%
28/757 • Number of events 30 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.0%
76/1515 • Number of events 110 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
4.1%
31/757 • Number of events 42 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.5%
83/1515 • Number of events 91 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
6.2%
47/757 • Number of events 52 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.9%
120/1515 • Number of events 258 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.79%
6/757 • Number of events 6 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
General disorders
Fatigue
|
16.0%
243/1515 • Number of events 579 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
6.6%
50/757 • Number of events 85 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Nervous system disorders
Headache
|
8.5%
129/1515 • Number of events 241 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
5.3%
40/757 • Number of events 50 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
General disorders
Influenza like illness
|
13.1%
198/1515 • Number of events 682 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
3.0%
23/757 • Number of events 39 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
General disorders
Injection site erythema
|
6.9%
104/1515 • Number of events 344 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
0.40%
3/757 • Number of events 3 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
General disorders
Injection site pain
|
31.4%
476/1515 • Number of events 1880 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
4.6%
35/757 • Number of events 73 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
General disorders
Injection site reaction
|
18.0%
273/1515 • Number of events 1368 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
1.8%
14/757 • Number of events 17 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.1%
183/1515 • Number of events 588 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
2.6%
20/757 • Number of events 23 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Gastrointestinal disorders
Nausea
|
7.1%
108/1515 • Number of events 177 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
4.8%
36/757 • Number of events 45 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
General disorders
Pain
|
15.6%
237/1515 • Number of events 578 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
1.8%
14/757 • Number of events 26 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
125/1515 • Number of events 251 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
3.2%
24/757 • Number of events 29 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
|
General disorders
Pyrexia
|
34.9%
529/1515 • Number of events 1732 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
5.0%
38/757 • Number of events 49 • From screening (Day 0) up to data lock point (DLP) on 23 January 2014, for up to 5 years per patient.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER