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An Effectiveness Study Comparing Fluticasone Furoate (FF, GW685698)/Vilanterol (VI, GW642444) With Standard Treatment in Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01706198
Recruitment Status : Completed
First Posted : October 15, 2012
Results First Posted : January 24, 2019
Last Update Posted : January 24, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: fluticasone furoate + vilanterol
Drug: inhaled corticosteroid with or without a long acting beta2-agonist
Enrollment 4233
Recruitment Details This was a multi-center, randomized, open label study to evaluate the effectiveness of fluticasone furoate (FF)/vilanterol (VI) Inhalation Powder (FF 100 micrograms [mcg]/VI 25 mcg or FF 200 mcg/VI 25 mcg) compared with usual asthma maintenance therapy in participants with asthma in a localized geographical region of United Kingdom.
Pre-assignment Details A total of 4725 participants were screened of which 4233 participants were randomized to either initiate with FF/VI or continue their usual asthma maintenance therapy in a ratio of 1:1. The total duration of study was approximately 12 months (52 weeks).
Arm/Group Title Usual Care FF/VI
Hide Arm/Group Description Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers). Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
Period Title: Overall Study
Started 2119 2114
Completed 1946 1920
Not Completed 173 194
Reason Not Completed
Adverse Event             12             15
Protocol Violation             7             5
Other: Subject reached stopping criteria             11             13
Lost to Follow-up             97             93
Physician Decision             23             37
Withdrawal by Subject             23             31
Arm/Group Title Usual Care FF/VI Total
Hide Arm/Group Description Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers). Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler. Total of all reporting groups
Overall Number of Baseline Participants 2119 2114 4233
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2119 participants 2114 participants 4233 participants
49.7  (16.69) 49.9  (16.05) 49.8  (16.37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2119 participants 2114 participants 4233 participants
Female
1241
  58.6%
1257
  59.5%
2498
  59.0%
Male
878
  41.4%
857
  40.5%
1735
  41.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Count of Participants
Number Analyzed 2119 participants 2114 participants 4233 participants
African American/African Heritage 25 40 65
Asian - Central/South Asian Heritage 35 46 81
Asian - East Asian Heritage 4 9 13
Asian - Japanese Heritage 2 0 2
Asian - South East Asian Heritage 9 18 27
Native Hawaiian or Other Pacific Islander 1 1 2
White - Arabic/North African Heritage 6 5 11
White - White/Caucasian/European Heritage 2002 1971 3973
Mixed race 33 23 56
Unknown 2 1 3
1.Primary Outcome
Title Percentage of Participants Who Have Either an Asthma Control Test (ACT) Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Week 24.
Hide Description The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of <=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and >=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The primary efficacy analysis (PEA) Population is defined as all Intent-to-Treat (ITT) participants (that is, all participants who were randomized and received at least one prescription of study medication) who have an ACT total score of <20 at Baseline (Day 0). The percentage of responders that is participants with an ACT total score >=20 or an increase from Baseline of >=3 has been presented
Time Frame Baseline (Day 0) and Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
PEA Population. Only participants with non-missing ACT score were analyzed.
Arm/Group Title Usual Care FF/VI
Hide Arm/Group Description:
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
Overall Number of Participants Analyzed 1399 1373
Measure Type: Number
Unit of Measure: Percentage of participants
56 71
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The analysis method was logistic regression adjusted for randomized treatment, asthma maintenance therapy (AMT) at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Odds Ratio
Estimated Value 2.00
Confidence Interval (2-Sided) 95%
1.70 to 2.34
Estimation Comments Adjusted odds ratio comparing FF/VI with Usual Care has been presented.
2.Secondary Outcome
Title Percentage of Participants Who Have Either an ACT Total Score of >=20 or an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 40 and 52.
Hide Description The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of <=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and >=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. ITT Population comprised of all participants who were randomized and received at least one prescription of study medication. The percentage of responders that is participants with an ACT total score >=20 or an increase from Baseline of >=3 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame Baseline (Day 0) and Weeks 12, 40 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Usual Care FF/VI
Hide Arm/Group Description:
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
Overall Number of Participants Analyzed 2119 2114
Measure Type: Number
Unit of Measure: Percentage of participants
Week 12, n=2032, 2009 Number Analyzed 2032 participants 2009 participants
62 75
Week 40, n=1938, 1904 Number Analyzed 1938 participants 1904 participants
60 71
Week 52, n=1922, 1896 Number Analyzed 1922 participants 1896 participants
58 70
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Odds Ratio
Estimated Value 1.92
Confidence Interval (2-Sided) 95%
1.67 to 2.20
Estimation Comments Adjusted odds ratio comparing FF/VI with Usual Care for Week 12 has been presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Odds Ratio
Estimated Value 1.66
Confidence Interval (2-Sided) 95%
1.45 to 1.91
Estimation Comments Adjusted odds ratio comparing FF/VI with Usual Care for Week 40 has been presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, Baseline ACT total score squared, gender and age.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Odds Ratio
Estimated Value 1.76
Confidence Interval (2-Sided) 95%
1.54 to 2.02
Estimation Comments Adjusted odds ratio comparing FF/VI with Usual Care for Week 52 has been presented.
3.Secondary Outcome
Title Percentage of Participants With Asthma Control (ACT Total Score >=20) at Weeks 12, 24, 40 and 52.
Hide Description The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of <=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and >=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants with an ACT total score >=20 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame Weeks 12, 24, 40 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Usual Care FF/VI
Hide Arm/Group Description:
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
Overall Number of Participants Analyzed 2119 2114
Measure Type: Number
Unit of Measure: Percentage of participants
Week 12, n=2032, 2009 Number Analyzed 2032 participants 2009 participants
46 61
Week 24, n=1957, 1936 Number Analyzed 1957 participants 1936 participants
46 60
Week 40, n=1938, 1904 Number Analyzed 1938 participants 1904 participants
45 58
Week 52, n=1922, 1896 Number Analyzed 1922 participants 1896 participants
44 58
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Odds Ratio
Estimated Value 2.09
Confidence Interval (2-Sided) 95%
1.82 to 2.40
Estimation Comments Adjusted odds ratio comparing FF/VI with Usual Care at Week 12 has been presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Odds Ratio
Estimated Value 1.96
Confidence Interval (2-Sided) 95%
1.70 to 2.25
Estimation Comments Adjusted odds ratio comparing FF/VI with Usual Care at Week 24 has been presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Odds Ratio
Estimated Value 1.79
Confidence Interval (2-Sided) 95%
1.56 to 2.06
Estimation Comments Adjusted odds ratio comparing FF/VI with Usual Care at Week 40 has been presented.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Odds Ratio
Estimated Value 1.95
Confidence Interval (2-Sided) 95%
1.69 to 2.24
Estimation Comments Adjusted odds ratio comparing FF/VI with Usual Care at Week 52 has been presented.
4.Secondary Outcome
Title Percentage of Participants Who Have an Increase From Baseline of >=3 in ACT Total Score at Weeks 12, 24, 40 and 52.
Hide Description The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of <=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and >=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants with an increase in ACT total score >=3 from Baseline has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame Baseline (Day 0) and Weeks 12, 24, 40 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Usual Care FF/VI
Hide Arm/Group Description:
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
Overall Number of Participants Analyzed 2119 2114
Measure Type: Number
Unit of Measure: Percentage of participants
Week 12, n=2032, 2009 Number Analyzed 2032 participants 2009 participants
39 55
Week 24, n=1957, 1936 Number Analyzed 1957 participants 1936 participants
40 54
Week 40, n=1938, 1904 Number Analyzed 1938 participants 1904 participants
42 53
Week 52, n=1922, 1896 Number Analyzed 1922 participants 1896 participants
37 50
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Odds Ratio
Estimated Value 2.28
Confidence Interval (2-Sided) 95%
1.98 to 2.62
Estimation Comments Adjusted odds ratio comparing FF/VI with Usual Care at Week 12 has been presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Odds Ratio
Estimated Value 2.09
Confidence Interval (2-Sided) 95%
1.81 to 2.41
Estimation Comments Adjusted odds ratio comparing FF/VI with Usual Care at Week 24 has been presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Odds Ratio
Estimated Value 1.76
Confidence Interval (2-Sided) 95%
1.53 to 2.02
Estimation Comments Adjusted odds ratio comparing FF/VI with Usual Care at Week 40 has been presented.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The analysis method was logistic regression adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, gender and age.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Odds Ratio
Estimated Value 1.91
Confidence Interval (2-Sided) 95%
1.66 to 2.21
Estimation Comments Adjusted odds ratio comparing FF/VI with Usual Care at Week 52 has been presented.
5.Secondary Outcome
Title Mean Change From Baseline in ACT Total Score at Weeks 12, 24, 40 and 52.
Hide Description The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of <=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and >=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. Baseline value is the value at Visit 2 (Day 0) assessment. Change from Baseline is the value at post-dose visit minus Baseline. The least square mean change in ACT scores has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame Baseline (Day 0) and Weeks 12, 24, 40 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Usual Care FF/VI
Hide Arm/Group Description:
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
Overall Number of Participants Analyzed 2119 2114
Least Squares Mean (Standard Error)
Unit of Measure: Scores on ACT scale
Week 12, n=2032, 2009 Number Analyzed 2032 participants 2009 participants
1.77  (0.087) 3.31  (0.087)
Week 24, n=1957, 1936 Number Analyzed 1957 participants 1936 participants
1.70  (0.093) 3.20  (0.094)
Week 40, n=1938, 1904 Number Analyzed 1938 participants 1904 participants
1.63  (0.096) 3.00  (0.097)
Week 52, n=1922, 1896 Number Analyzed 1922 participants 1896 participants
1.49  (0.094) 2.99  (0.095)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.
Method Mixed Model Repeated Measures (MMRM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.54
Confidence Interval (2-Sided) 95%
1.30 to 1.77
Estimation Comments Treatment difference of FF/VI versus Usual Care at Week 12 has been presented.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.50
Confidence Interval (2-Sided) 95%
1.25 to 1.76
Estimation Comments Treatment difference of FF/VI versus Usual Care at Week 24 has been presented.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.37
Confidence Interval (2-Sided) 95%
1.11 to 1.63
Estimation Comments Treatment difference of FF/VI versus Usual Care at Week 40 has been presented.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments MMRM adjusted for randomized treatment, AMT at Baseline per randomization stratification, Baseline ACT total score, randomized treatment-by-Baseline ACT total score interaction, gender, age, visit and randomized treatment by visit interaction.
Method MMRM
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.50
Confidence Interval (2-Sided) 95%
1.24 to 1.76
Estimation Comments Treatment difference of FF/VI versus Usual Care at Week 52 has been presented.
6.Secondary Outcome
Title Percentage of Participants in Each ACT Total Score Category (>=20, 16 to 19, <=15) at Weeks 12, 24, 40 and 52.
Hide Description The ACT is a validated self-administered questionnaire utilizing 5 questions to assess asthma control during the past 4 weeks on a 5-point categorical scale (1 to 5). By answering all 5 questions, participants with asthma obtained an ACT score ranging between 5 and 25. Higher scores indicated better control of asthma. An ACT score of <=15 showed poorly controlled asthma; 16 to 19 showed partly controlled asthma and >=20 showed well controlled asthma. The total score was calculated as the sum of the scores from all 5 questions. The percentage of participants under each ACT total score category that is >=20, 16 to 19 and <=15 has been presented. Only those participants with data available at the specified data points were analyzed (represented by n=X in category title).
Time Frame Weeks 12, 24, 40 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Usual Care FF/VI
Hide Arm/Group Description:
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
Overall Number of Participants Analyzed 2119 2114
Measure Type: Number
Unit of Measure: Percentage of participants
>=20, Week 12, n=2032, 2009 Number Analyzed 2032 participants 2009 participants
46 61
16 to 19, Week 12, n=2032, 2009 Number Analyzed 2032 participants 2009 participants
26 20
<=15, Week 12, n=2032, 2009 Number Analyzed 2032 participants 2009 participants
28 18
>=20, Week 24, n=1957, 1936 Number Analyzed 1957 participants 1936 participants
46 60
16 to 19, Week 24, n=1957, 1936 Number Analyzed 1957 participants 1936 participants
25 20
<=15, Week 24, n=1957, 1936 Number Analyzed 1957 participants 1936 participants
29 20
>=20, Week 40, n=1938, 1904 Number Analyzed 1938 participants 1904 participants
45 58
16 to 19, Week 40, n=1938, 1904 Number Analyzed 1938 participants 1904 participants
24 21
<=15, Week 40, n=1938, 1904 Number Analyzed 1938 participants 1904 participants
31 21
>=20, Week 52, n=1922, 1896 Number Analyzed 1922 participants 1896 participants
44 58
16 to 19, Week 52, n=1922, 1896 Number Analyzed 1922 participants 1896 participants
26 20
<=15, Week 52, n=1922, 1896 Number Analyzed 1922 participants 1896 participants
30 21
7.Secondary Outcome
Title Annual Rate of Asthma-related Secondary Care Contacts
Hide Description All contacts are defined as any encounter the participant may have with a doctor, nurse or other healthcare professionals working as part of the National Health Service (NHS) as identified in the electronic medical records (EMR). Contacts were defined to be asthma-related if the most prominent signs and symptoms that the participant presented were a direct result of the participant's asthma. An asthma-related secondary care contact is defined as an inpatient admission or a specialist outpatient visit or an accident and emergency (A&E) contact. A participant with an A&E contact and subsequent inpatient admission was considered to have had two healthcare contacts. The least square mean annual rate of all asthma-related secondary care contacts along with 95% confidence interval has been presented.
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Usual Care FF/VI
Hide Arm/Group Description:
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
Overall Number of Participants Analyzed 2119 2114
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Contacts per participant per year
0.30
(0.25 to 0.34)
0.30
(0.26 to 0.36)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.786
Comments GLM assuming negative binomial distribution (NBD) adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age
Method Generalized Linear Model (GLM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.83 to 1.28
Estimation Comments Ratio comparing FF/VI with Usual Care has been presented.
8.Secondary Outcome
Title Annual Rate of Asthma-related Primary Care Contacts
Hide Description All contacts are defined as any encounter the participant may have with a doctor, nurse or other healthcare professionals working as part of the NHS as identified in the EMR. Contacts were defined to be asthma-related if the most prominent signs and symptoms that the participant presented were a direct result of the participant's asthma. Asthma-related primary care contacts is defined as the sum of primary care contacts on a given calendar date with either a nurse, General Practitioner or other healthcare professional that can be considered as asthma-related as per Read codes. The least square mean annual rate of all asthma-related primary care contacts along with 95% confidence interval has been presented.
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Usual Care FF/VI
Hide Arm/Group Description:
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
Overall Number of Participants Analyzed 2119 2114
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Contacts per participant per year
1.42
(1.36 to 1.47)
1.45
(1.39 to 1.51)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.461
Comments GLM assuming NBD adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age
Method Generalized Linear Model (GLM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.02
Confidence Interval (2-Sided) 95%
0.97 to 1.08
Estimation Comments Ratio comparing FF/VI with Usual Care has been presented.
9.Secondary Outcome
Title Number of Participants With Time to First Asthma-related Primary Care Contact
Hide Description Asthma-related primary care contact is defined as the sum of primary care contacts on a given calendar date with either a nurse, General Practitioner or other healthcare professional that can be considered as asthma-related as per Read codes. Time to first asthma-related primary care contact was measured from the date of randomization (that is, study treatment start date) to the date of first asthma-related primary care contact, or study treatment stop date for participants who completed the study without any asthma-related primary care contacts (censored). Analyses of time to first asthma-related primary care contact was censored at Day 364. The number of participants at risk at Weeks 0, 13, 26, 39 and 52 has been presented. Kaplan Meier method of analysis was used. Study related primary care contacts (that is, contacts scheduled solely due to the participant taking part in clinical trial) were excluded from this analysis.
Time Frame Up to Week 52
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ITT Population
Arm/Group Title Usual Care FF/VI
Hide Arm/Group Description:
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
Overall Number of Participants Analyzed 2119 2114
Measure Type: Number
Unit of Measure: Participants
Week 0 2119 2114
Week 13 1621 1599
Week 26 1208 1214
Week 39 907 932
Week 52 479 488
10.Secondary Outcome
Title Annual Rate of All On-treatment Secondary Care Contacts
Hide Description A secondary care contact is defined as an inpatient admission or a specialist outpatient visit or an A&E contact. A participant with an A&E contact and subsequent inpatient admission was considered to have had two healthcare contacts. The inpatient admissions recorded at two hospitals on the same day, were counted as a single (inpatient admission) secondary care contact. In the situation where inpatient admission periods overlapped (example, a new inpatient admission was recorded within the dates of an existing inpatient admission period), it was counted as a single (inpatient admission) healthcare contact with start date defined as the earliest inpatient admission date for either of the overlapping admissions and end date defined as the latest discharge date for either of the overlapping admissions. The least square mean annual rate of all on-treatment secondary care contacts along with 95% confidence interval has been summarized.
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Usual Care FF/VI
Hide Arm/Group Description:
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
Overall Number of Participants Analyzed 2119 2114
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Contacts per participant per year
5.23
(4.91 to 5.57)
5.17
(4.86 to 5.51)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.822
Comments GLM assuming NBD adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age
Method Generalized Linear Model (GLM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.91 to 1.08
Estimation Comments Ratio comparing FF/VI with Usual Care has been presented.
11.Secondary Outcome
Title Annual Rate of All On-treatment Primary Care Contacts
Hide Description All contacts are defined as any encounter the participant may have with a doctor, nurse or other healthcare professionals working as part of the NHS as identified in the EMR. Total primary care contacts is defined as the sum of primary care contacts on a given calendar date with either a nurse, General Practitioner or other healthcare professional. The least square mean annual rate of all on-treatment primary care contacts along with 95% confidence interval has been presented.
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Usual Care FF/VI
Hide Arm/Group Description:
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
Overall Number of Participants Analyzed 2119 2114
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Contacts per participant per year
10.61
(10.26 to 10.98)
11.64
(11.25 to 12.04)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments GLM assuming NBD adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age
Method Generalized Linear Model (GLM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 1.10
Confidence Interval (2-Sided) 95%
1.05 to 1.15
Estimation Comments Ratio comparing FF/VI with Usual Care has been presented.
12.Secondary Outcome
Title Number of Participants With Time to First Primary Care Contact
Hide Description Time to first primary care contact is measured from the date of randomization (that is, study treatment start date) to the date of first primary care contact, or study treatment stop date for participants who completed the study without any primary care contacts (censored). Analyses of time to first primary care contact will be censored at Day 364. The number of participants at risk at Weeks 0, 13, 26, 39 and 52 has been presented. Kaplan Meier method of analysis was used. Study related primary care contacts (that is, contacts scheduled solely due to the participant taking part in clinical trial) were excluded from this analysis.
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Usual Care FF/VI
Hide Arm/Group Description:
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
Overall Number of Participants Analyzed 2119 2114
Measure Type: Number
Unit of Measure: Participants
Week 0 2119 2114
Week 13 513 483
Week 26 245 242
Week 39 160 178
Week 52 79 96
13.Secondary Outcome
Title Mean Annual Rate of Severe Asthma Exacerbations
Hide Description A severe asthma exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) or antibiotics, and inpatient hospitalization, or emergency department visit due to asthma that required systemic corticosteroids or antibiotics. Least square mean for annual rate of severe asthma exacerbation along with 95% confidence interval has been presented.
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Usual Care FF/VI
Hide Arm/Group Description:
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
Overall Number of Participants Analyzed 2119 2114
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Exacerbations per participant per year
0.41
(0.38 to 0.44)
0.40
(0.37 to 0.43)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.697
Comments GLM assuming NBD adjusted for randomized treatment; asthma maintenance therapy and ACT total score at Baseline per randomization stratification; number of severe asthma exacerbations in previous year prior to randomization categorized; gender & age
Method Generalized Linear Model (GLM)
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio
Estimated Value 0.98
Confidence Interval (2-Sided) 95%
0.88 to 1.09
Estimation Comments Ratio comparing FF/VI with Usual Care has been presented.
14.Secondary Outcome
Title Time to First Severe Asthma Exacerbation.
Hide Description A severe asthma exacerbation is defined as deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) or antibiotics, and inpatient hospitalization, or emergency department visit due to asthma that required systemic corticosteroids or antibiotics. The date of a severe asthma exacerbation was defined as the exacerbation onset date. Participants who completed the study without a severe asthma exacerbation were censored. Time to first severe asthma exacerbation was measured from the date of randomization (that is, study treatment start date) to the onset date of first severe asthma exacerbation, or study treatment stop date for participants who completed the study without any severe asthma exacerbations (censored). Analyses of time to first severe asthma exacerbation was censored at Day 364. The number of participants with severe asthma exacerbation has been presented.
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Usual Care FF/VI
Hide Arm/Group Description:
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
Overall Number of Participants Analyzed 2119 2114
Measure Type: Number
Unit of Measure: Participants
654 634
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.504
Comments Cox proportional hazards model with randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age as covariates
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.96
Confidence Interval (2-Sided) 95%
0.86 to 1.07
Estimation Comments A hazard ratio <1 indicated a lower risk with FF/VI compared with Usual Care
15.Secondary Outcome
Title Mean Number of Salbutamol Inhalers Prescribed for Each Participant Over the 12 Month Treatment Period.
Hide Description Salbutamol was prescribed as a rescue medication to be used as and when necessary throughout the study. The number of salbutamol inhalers used by each participant during the study was calculated based on the total number of inhalers (adjusted to an equivalence of 200 metered actuations) prescribed. Number of salbutamol inhalers prescribed during the study was derived taking the participants time on study medication into account so it corresponds to 12 months on treatment. The least square mean number of salbutamol inhalers prescribed per participant during the study has been presented. Only participants exposed to study drug for at least 30 days were included in the analysis.
Time Frame Up to 12 months
Hide Outcome Measure Data
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ITT Population
Arm/Group Title Usual Care FF/VI
Hide Arm/Group Description:
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
Overall Number of Participants Analyzed 2116 2108
Least Squares Mean (Standard Error)
Unit of Measure: Mean number of inhalers per participant
8.0  (0.11) 7.2  (0.11)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments ANCOVA adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender,age & number of salbutamol inhalers in year prior to randomization
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.8
Confidence Interval (2-Sided) 95%
-1.1 to -0.5
Estimation Comments Difference of FF/VI versus Usual Care has been presented.
16.Secondary Outcome
Title Time to Modification of Initial Therapy
Hide Description Initial therapy is defined as the treatment that the participant was prescribed at randomization. Modification of initial therapy included any change in brand, dose or frequency of inhaler, that is, stepping up in class, dose or frequency, stepping down in class, dose or frequency, switching to another brand of inhaler, switching treatment arm or withdrawal from the study. Time to modification of initial therapy was measured from the date of randomization (that is, exposure start date) to the date of modification of initial therapy or date of treatment termination for participants who completed the study without modifiying initial therapy (censored). The number of participants with modification of initial therapy has been presented.
Time Frame Up to Week 52
Hide Outcome Measure Data
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ITT Population
Arm/Group Title Usual Care FF/VI
Hide Arm/Group Description:
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
Overall Number of Participants Analyzed 2119 2114
Measure Type: Number
Unit of Measure: Participants
488 563
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Cox proportional hazards model with randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age as covariates
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.23
Confidence Interval (2-Sided) 95%
1.09 to 1.38
Estimation Comments Hazard ratio for FF/VI versus Usual Care has been presented
17.Secondary Outcome
Title Percentage of Participants Who Have an Increase From Baseline of >=0.5 in Standardized Asthma Quality of Life Questionnaire [AQLQ(S)] Total Score at Week 52.
Hide Description The AQLQ(S) contained 32 items under the following four domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items) and environmental stimuli (4 items). The response format consisted of a seven-point scale where a value of 1 indicated "total impairment" and a value of 7 indicated "no impairment". The total AQLQ(S) score is the mean of all 32 items in the questionnaire and each individual domain score was calculated as the mean of the items within that domain. Hence, the total and domain scores were each defined on a range from 1 to 7 with higher scores indicating a higher quality of life. Baseline value is the value at Day 0 assessment. Change from Baseline is post dose visit value minus Baseline. The percentage of responders that is, participants with an increase from Baseline of >=0.5 in AQLQ(S) total score has been presented. Only those participants available at the specified time point was analyzed.
Time Frame Baseline (Day 0) and Week 52
Hide Outcome Measure Data
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ITT Population
Arm/Group Title Usual Care FF/VI
Hide Arm/Group Description:
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
Overall Number of Participants Analyzed 1922 1896
Measure Type: Number
Unit of Measure: Percentage of participants
43 55
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Logistic regression adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender, age and Baseline score.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Odds Ratio
Estimated Value 1.79
Confidence Interval (2-Sided) 95%
1.55 to 2.06
Estimation Comments Adjusted odds ratio of FF/VI with Usual Care has been presented.
18.Secondary Outcome
Title Percentage of Participants Who Have an Increase From Baseline of >=0.5 in AQLQ(S) Environmental Stimuli Domain Score at Week 52.
Hide Description The AQLQ(S) contained 32 items under the following four domains: activity limitation (11 items), symptoms (12 items), emotional function (5 items) and environmental stimuli (4 items). The response format consisted of a seven-point scale where a value of 1 indicated "total impairment" and a value of 7 indicated "no impairment". The total environmental stimuli domain score was calculated as the mean of the items within the environmental stimuli domain. Hence, the environmental stimuli domain scores were each defined on a range from 1 to 7 with higher scores indicating a higher quality of life. Baseline value is the value at Day 0 assessment. Change from Baseline is post dose visit value minus Baseline. The percentage of responders that is, participants with an increase from Baseline of >=0.5 in AQLQ(S) environmental stimuli domain score has been presented. Only those participants available at the specified time point was analyzed.
Time Frame Baseline (Day 0) and Week 52
Hide Outcome Measure Data
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ITT Population
Arm/Group Title Usual Care FF/VI
Hide Arm/Group Description:
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
Overall Number of Participants Analyzed 1922 1896
Measure Type: Number
Unit of Measure: Percentage of participants
50 59
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments Logistic regression adjusted for randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender, age and Baseline score.
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Adjusted Odds Ratio
Estimated Value 1.51
Confidence Interval (2-Sided) 95%
1.31 to 1.73
Estimation Comments Adjusted odds ratio of FF/VI versus Usual Care has been presented.
19.Secondary Outcome
Title Percentage of Participants With Serious Adverse Event (SAE) of Pneumonia
Hide Description A serious advent event (SAE) of pneumonia was defined as any SAE in the adverse event special interest (AESI) group of "pneumonia". The incidence of the SAEs of pneumonia for each treatment group is defined as the percentage of participants in that group who have experienced at least one SAE of pneumonia from start date of study treatment to the stop date of exposure + 28 days or date of study discontinuation, whichever is earliest. The percentage of participants with SAE of pneumonia has been presented.
Time Frame Up to Week 52
Hide Outcome Measure Data
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ITT Population
Arm/Group Title Usual Care FF/VI
Hide Arm/Group Description:
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
Overall Number of Participants Analyzed 2119 2114
Measure Type: Number
Unit of Measure: Percentage of participants
1 1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments Non-inferiority is demonstrated if the upper limit of the two-sided 95% confidence interval for the incidence ratio is less than 2.
Method of Estimation Estimation Parameter Incidence ratio
Estimated Value 1.4
Confidence Interval (2-Sided) 95%
0.8 to 2.7
Estimation Comments Incidence ratio was calculated as percentage of participants who had at least one SAE of pneumonia in the FF/VI group divided by the percentage of participants who had at least one SAE of pneumonia in the Usual Care group.
20.Secondary Outcome
Title Time to First SAE of Pneumonia
Hide Description An SAE of pneumonia was defined as any SAE in the AESI group of "pneumonia". The date of an event for an SAE of pneumonia was the AE onset date. Participants who do not have an SAE of pneumonia during the first 364 days of the treatment period (start date of exposure to min [end date of exposure + 28 days, date of study discontinuation, start date of exposure + 363]) were censored. Time to first SAE of pneumonia was measured from the date of randomization (that is, study treatment start date) to the onset date of first SAE of pneumonia. The number of participants with first on-treatment SAE of pneumonia has been presented.
Time Frame Up to Week 52
Hide Outcome Measure Data
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ITT Population
Arm/Group Title Usual Care FF/VI
Hide Arm/Group Description:
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
Overall Number of Participants Analyzed 2119 2114
Measure Type: Number
Unit of Measure: Participants
16 23
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, FF/VI
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.255
Comments Cox proportional hazards model with randomized treatment, asthma maintenance therapy at Baseline per randomization stratification, ACT total score at Baseline per randomization stratification, gender and age as covariates.
Method Cox proportional hazards model
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.45
Confidence Interval (2-Sided) 95%
0.77 to 2.74
Estimation Comments Hazard ratio for FF/VI versus Usual Care has been presented.
21.Secondary Outcome
Title Number of Participants With Fatal SAEs of Pneumonia
Hide Description All SAEs included in the AESI group of "pneumonia" were considered as an SAE of pneumonia. Fatal SAEs of pneumonia are SAEs that led to death of participants. The number of participants with fatal SAEs of pneumonia has been presented.
Time Frame Up to Week 52
Hide Outcome Measure Data
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ITT Population
Arm/Group Title Usual Care FF/VI
Hide Arm/Group Description:
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
Overall Number of Participants Analyzed 2119 2114
Measure Type: Number
Unit of Measure: Participants
3 1
22.Secondary Outcome
Title Number of Participants With SAEs
Hide Description An SAE is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization; results in disability/incapacity; is a congenital anomaly/birth defect; important medical events which may require medical or surgical intervention for example, invasive or malignant cancers; all events of possible drug-induced liver injury with hyperbilirubinemia. The number of participants with on-treatment SAEs has been summarized.
Time Frame Up to Week 52
Hide Outcome Measure Data
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ITT Population
Arm/Group Title Usual Care FF/VI
Hide Arm/Group Description:
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
Overall Number of Participants Analyzed 2119 2114
Measure Type: Number
Unit of Measure: Participants
284 284
23.Secondary Outcome
Title Number of Participants With Adverse Drug Reactions (ADRs)
Hide Description An ADR is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, for which there is a reasonable possibility that the untoward occurrence is causally related to the medicinal product. ADRs are a subset of AEs for a given medicinal product.
Time Frame Up to Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Usual Care FF/VI
Hide Arm/Group Description:
Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers).
Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
Overall Number of Participants Analyzed 2119 2114
Measure Type: Number
Unit of Measure: Participants
109 326
Time Frame On-treatment serious adverse events (SAEs) and non- serious adverse drug reactions (ADRs) were collected from the start of study treatment and until the follow up contact (Up to Week 52).
Adverse Event Reporting Description ITT Population comprised of all randomized participants who received at least one prescription of study medication
 
Arm/Group Title Usual Care FF/VI
Hide Arm/Group Description Participants continued their usual asthma maintenance therapy that is, inhaled corticosteroid without a long acting beta2-agonist or inhaled corticosteroid with long acting beta2-agonist combination (either as a fixed dose combination or an inhaled corticosteroid/long acting beta2-agonist provided in two separate inhalers). Participants initiated with an appropriate dose of inhaled FF/VI (100 mcg/25 mcg or 200 mcg/25 mcg per actuation) once daily via Novel Dry Powder Inhaler.
All-Cause Mortality
Usual Care FF/VI
Affected / at Risk (%) Affected / at Risk (%)
Total   27/2119 (1.27%)      15/2114 (0.71%)    
Hide Serious Adverse Events
Usual Care FF/VI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   284/2119 (13.40%)      284/2114 (13.43%)    
Blood and lymphatic system disorders     
Anaemia  1  3/2119 (0.14%)  3 3/2114 (0.14%)  3
Anaemia of chronic disease  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Lymphadenopathy mediastinal  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Microcytic anaemia  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Pancytopenia  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Thrombocytopenia  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Cardiac disorders     
Acute coronary syndrome  1  1/2119 (0.05%)  2 1/2114 (0.05%)  1
Acute myocardial infarction  1  2/2119 (0.09%)  2 4/2114 (0.19%)  4
Angina pectoris  1  1/2119 (0.05%)  1 5/2114 (0.24%)  5
Angina unstable  1  2/2119 (0.09%)  2 0/2114 (0.00%)  0
Arrhythmia  1  3/2119 (0.14%)  3 2/2114 (0.09%)  2
Arteriosclerosis coronary artery  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Atrial fibrillation  1  14/2119 (0.66%)  16 7/2114 (0.33%)  7
Atrioventricular block first degree  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Cardiac arrest  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Cardiac failure  1  0/2119 (0.00%)  0 2/2114 (0.09%)  2
Cardiac failure congestive  1  2/2119 (0.09%)  2 1/2114 (0.05%)  1
Cardiac ventricular thrombosis  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Coronary artery disease  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Coronary artery thrombosis  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Diastolic dysfunction  1  2/2119 (0.09%)  2 0/2114 (0.00%)  0
Hypertensive heart disease  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Left ventricular dysfunction  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Left ventricular failure  1  0/2119 (0.00%)  0 3/2114 (0.14%)  3
Left ventricular hypertrophy  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Myocardial infarction  1  2/2119 (0.09%)  2 2/2114 (0.09%)  2
Myocardial ischaemia  1  2/2119 (0.09%)  2 5/2114 (0.24%)  5
Myocarditis  1  0/2119 (0.00%)  0 2/2114 (0.09%)  2
Palpitations  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Sinus bradycardia  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Sinus node dysfunction  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Tricuspid valve incompetence  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Ventricular extrasystoles  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Ventricular tachycardia  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Congenital, familial and genetic disorders     
Branchial cyst  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Endocardial fibroelastosis  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Ear and labyrinth disorders     
Deafness  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Tinnitus  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Vertigo  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Vertigo positional  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Endocrine disorders     
Adrenal insufficiency  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Hyperparathyroidism  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Hyperthyroidism  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Hypothyroidism  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Inappropriate antidiuretic hormone secretion  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Secondary hypogonadism  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Eye disorders     
Angle closure glaucoma  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Cataract  1  4/2119 (0.19%)  4 6/2114 (0.28%)  6
Conjunctivitis allergic  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Diabetic retinopathy  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Glaucoma  1  0/2119 (0.00%)  0 4/2114 (0.19%)  4
Ocular hyperaemia  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Retinal detachment  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Gastrointestinal disorders     
Abdominal hernia  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Abdominal pain  1  4/2119 (0.19%)  4 5/2114 (0.24%)  5
Abdominal wall haematoma  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Colitis ischaemic  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Colitis ulcerative  1  0/2119 (0.00%)  0 1/2114 (0.05%)  2
Constipation  1  5/2119 (0.24%)  5 1/2114 (0.05%)  1
Diarrhoea  1  0/2119 (0.00%)  0 4/2114 (0.19%)  4
Diverticulum  1  0/2119 (0.00%)  0 2/2114 (0.09%)  2
Duodenal ulcer  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Dysphagia  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Gastritis  1  5/2119 (0.24%)  5 1/2114 (0.05%)  1
Gastrointestinal disorder  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Gastrointestinal haemorrhage  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Gastrooesophageal reflux disease  1  2/2119 (0.09%)  2 3/2114 (0.14%)  3
Haematemesis  1  2/2119 (0.09%)  2 0/2114 (0.00%)  0
Incarcerated umbilical hernia  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Intestinal ischaemia  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Intestinal obstruction  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Large intestinal obstruction  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Melaena  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Oesophagitis  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Pancreatitis  1  1/2119 (0.05%)  1 3/2114 (0.14%)  3
Pancreatitis acute  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Proctalgia  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Rectal haemorrhage  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Umbilical hernia, obstructive  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Upper gastrointestinal haemorrhage  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Vomiting  1  1/2119 (0.05%)  1 2/2114 (0.09%)  2
General disorders     
Chest pain  1  4/2119 (0.19%)  4 1/2114 (0.05%)  1
Generalised oedema  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Multiple organ dysfunction syndrome  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Non-cardiac chest pain  1  3/2119 (0.14%)  3 1/2114 (0.05%)  1
Peripheral swelling  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Surgical failure  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Hepatobiliary disorders     
Bile duct stone  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Cholecystitis  1  3/2119 (0.14%)  3 1/2114 (0.05%)  2
Cholelithiasis  1  1/2119 (0.05%)  1 3/2114 (0.14%)  3
Hepatic cirrhosis  1  2/2119 (0.09%)  2 1/2114 (0.05%)  1
Hepatic failure  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Hepatic function abnormal  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Jaundice cholestatic  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Immune system disorders     
Anaphylactic reaction  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Hypersensitivity  1  2/2119 (0.09%)  2 0/2114 (0.00%)  0
Mycotic allergy  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Infections and infestations     
Abdominal abscess  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Abdominal wall abscess  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Abscess  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Anal abscess  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Appendicitis  1  2/2119 (0.09%)  2 1/2114 (0.05%)  1
Atypical pneumonia  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Bacteraemia  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Biliary sepsis  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Bronchiolitis  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Candida infection  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Catheter site infection  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Cellulitis  1  11/2119 (0.52%)  13 7/2114 (0.33%)  8
Chronic hepatitis C  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Diverticulitis  1  1/2119 (0.05%)  1 3/2114 (0.14%)  3
Empyema  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Encephalitis  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Gastroenteritis  1  0/2119 (0.00%)  0 2/2114 (0.09%)  2
Genital herpes  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Genital infection  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Infected dermal cyst  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Infected skin ulcer  1  3/2119 (0.14%)  3 0/2114 (0.00%)  0
Infective exacerbation of chronic obstructive airways disease  1  0/2119 (0.00%)  0 2/2114 (0.09%)  2
Kidney infection  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Liver abscess  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Localised infection  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Lower respiratory tract infection  1  7/2119 (0.33%)  7 5/2114 (0.24%)  5
Necrotising fasciitis  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Neutropenic sepsis  1  1/2119 (0.05%)  1 2/2114 (0.09%)  2
Ophthalmic herpes simplex  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Pelvic inflammatory disease  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Periorbital cellulitis  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Peritonsillar abscess  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Pilonidal cyst  1  2/2119 (0.09%)  3 1/2114 (0.05%)  1
Pneumonia  1  13/2119 (0.61%)  14 23/2114 (1.09%)  24
Pneumonia mycoplasmal  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Post procedural infection  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Post procedural sepsis  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Postoperative wound infection  1  1/2119 (0.05%)  1 2/2114 (0.09%)  2
Pseudomonas infection  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Pyelonephritis  1  3/2119 (0.14%)  3 1/2114 (0.05%)  1
Respiratory tract infection  1  0/2119 (0.00%)  0 3/2114 (0.14%)  3
Sepsis  1  7/2119 (0.33%)  7 3/2114 (0.14%)  3
Sialoadenitis  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Staphylococcal infection  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Subcutaneous abscess  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Tonsillitis  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Upper respiratory tract infection  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Urinary tract infection  1  4/2119 (0.19%)  4 12/2114 (0.57%)  13
Urosepsis  1  2/2119 (0.09%)  2 1/2114 (0.05%)  1
Viral infection  1  2/2119 (0.09%)  2 1/2114 (0.05%)  1
Viral labyrinthitis  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Vulval abscess  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Wound infection  1  2/2119 (0.09%)  2 1/2114 (0.05%)  1
Injury, poisoning and procedural complications     
Accidental overdose  1  3/2119 (0.14%)  3 2/2114 (0.09%)  2
Ankle fracture  1  2/2119 (0.09%)  2 8/2114 (0.38%)  8
Brain contusion  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Burns third degree  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Cervical vertebral fracture  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Comminuted fracture  1  2/2119 (0.09%)  2 0/2114 (0.00%)  0
Corneal abrasion  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Craniocerebral injury  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Facial bones fracture  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Fall  1  5/2119 (0.24%)  5 6/2114 (0.28%)  6
Femoral neck fracture  1  2/2119 (0.09%)  2 2/2114 (0.09%)  2
Femur fracture  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Fibula fracture  1  2/2119 (0.09%)  2 1/2114 (0.05%)  1
Foot fracture  1  3/2119 (0.14%)  3 3/2114 (0.14%)  3
Foreign body  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Fracture  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Hand fracture  1  4/2119 (0.19%)  5 1/2114 (0.05%)  1
Head injury  1  3/2119 (0.14%)  3 1/2114 (0.05%)  1
Humerus fracture  1  5/2119 (0.24%)  5 2/2114 (0.09%)  2
Intentional overdose  1  5/2119 (0.24%)  5 5/2114 (0.24%)  5
Intentional product misuse  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Joint dislocation  1  2/2119 (0.09%)  2 0/2114 (0.00%)  0
Ligament rupture  1  0/2119 (0.00%)  0 1/2114 (0.05%)  2
Limb crushing injury  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Limb injury  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Meniscus injury  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Overdose  1  1/2119 (0.05%)  1 2/2114 (0.09%)  2
Pelvic fracture  1  2/2119 (0.09%)  2 1/2114 (0.05%)  1
Post procedural complication  1  0/2119 (0.00%)  0 2/2114 (0.09%)  2
Post procedural haematoma  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Post procedural haemorrhage  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Pubis fracture  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Radius fracture  1  9/2119 (0.42%)  10 4/2114 (0.19%)  4
Rib fracture  1  1/2119 (0.05%)  1 2/2114 (0.09%)  2
Skull fracture  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Skull fractured base  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Soft tissue injury  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Spinal fracture  1  1/2119 (0.05%)  1 2/2114 (0.09%)  2
Subarachnoid haemorrhage  1  0/2119 (0.00%)  0 2/2114 (0.09%)  2
Subdural haematoma  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Thermal burn  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Toxicity to various agents  1  1/2119 (0.05%)  1 2/2114 (0.09%)  2
Ulna fracture  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Upper limb fracture  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Wound secretion  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Wrist fracture  1  3/2119 (0.14%)  3 5/2114 (0.24%)  5
Investigations     
Blood potassium decreased  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Electrocardiogram QT prolonged  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
International normalised ratio abnormal  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Liver function test abnormal  1  7/2119 (0.33%)  7 11/2114 (0.52%)  11
Renal function test abnormal  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Metabolism and nutrition disorders     
Dehydration  1  2/2119 (0.09%)  2 1/2114 (0.05%)  1
Diabetes mellitus  1  3/2119 (0.14%)  3 3/2114 (0.14%)  3
Diabetic ketoacidosis  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Electrolyte imbalance  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Glucose tolerance impaired  1  2/2119 (0.09%)  2 0/2114 (0.00%)  0
Gout  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Hypercalcaemia  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Hyperglycaemia  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Hyperkalaemia  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Hypokalaemia  1  1/2119 (0.05%)  1 4/2114 (0.19%)  4
Hyponatraemia  1  2/2119 (0.09%)  2 0/2114 (0.00%)  0
Malnutrition  1  2/2119 (0.09%)  2 0/2114 (0.00%)  0
Metabolic acidosis  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Type 2 diabetes mellitus  1  13/2119 (0.61%)  13 12/2114 (0.57%)  12
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Arthritis  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Back pain  1  8/2119 (0.38%)  9 3/2114 (0.14%)  3
Bursitis  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Fibromyalgia  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Intervertebral disc protrusion  1  3/2119 (0.14%)  3 0/2114 (0.00%)  0
Metatarsalgia  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Muscular weakness  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Musculoskeletal chest pain  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Musculoskeletal pain  1  2/2119 (0.09%)  2 0/2114 (0.00%)  0
Osteoarthritis  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Osteopenia  1  0/2119 (0.00%)  0 2/2114 (0.09%)  2
Osteoporosis  1  1/2119 (0.05%)  1 5/2114 (0.24%)  5
Palindromic rheumatism  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Polymyalgia rheumatica  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Rhabdomyolysis  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Rheumatoid arthritis  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Acinic cell carcinoma of salivary gland  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Acute myeloid leukaemia  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Adenoma benign  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
B-cell lymphoma recurrent  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Basal cell carcinoma  1  2/2119 (0.09%)  6 4/2114 (0.19%)  4
Bladder cancer  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Bladder transitional cell carcinoma  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Brain cancer metastatic  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Brain neoplasm  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Breast cancer  1  2/2119 (0.09%)  2 2/2114 (0.09%)  2
Breast cancer metastatic  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Central nervous system lymphoma  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Chondrosarcoma  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Colon cancer  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Colorectal cancer metastatic  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Endometrial adenocarcinoma  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Gastrointestinal carcinoma  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Gastrointestinal stromal tumour  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Hepatocellular carcinoma  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Invasive ductal breast carcinoma  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Lentigo maligna  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Lung cancer metastatic  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Lung neoplasm malignant  1  0/2119 (0.00%)  0 2/2114 (0.09%)  2
Malignant melanoma  1  0/2119 (0.00%)  0 2/2114 (0.09%)  2
Malignant melanoma in situ  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Metastases to central nervous system  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Metastases to liver  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Metastases to lung  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Metastatic renal cell carcinoma  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Neoplasm malignant  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Oesophageal carcinoma  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Penile squamous cell carcinoma  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Phyllodes tumour  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Precursor B-lymphoblastic lymphoma  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Prostate cancer  1  4/2119 (0.19%)  4 3/2114 (0.14%)  3
Renal cancer  1  1/2119 (0.05%)  1 2/2114 (0.09%)  2
Renal cancer recurrent  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Renal neoplasm  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Squamous cell carcinoma  1  1/2119 (0.05%)  1 2/2114 (0.09%)  2
Thyroid cancer  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Ureteric cancer  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Nervous system disorders     
Amnesia  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Anosmia  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Carpal tunnel syndrome  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Cerebrovascular accident  1  0/2119 (0.00%)  0 5/2114 (0.24%)  5
Cerebrovascular disorder  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Dementia  1  1/2119 (0.05%)  1 2/2114 (0.09%)  2
Dizziness  1  2/2119 (0.09%)  2 0/2114 (0.00%)  0
Drug withdrawal convulsions  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Epilepsy  1  2/2119 (0.09%)  2 1/2114 (0.05%)  1
Haemorrhage intracranial  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Haemorrhagic stroke  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Headache  1  4/2119 (0.19%)  4 2/2114 (0.09%)  2
Ischaemic stroke  1  1/2119 (0.05%)  1 3/2114 (0.14%)  3
Migraine  1  2/2119 (0.09%)  2 5/2114 (0.24%)  5
Multiple sclerosis  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Multiple sclerosis relapse  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Neuralgia  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Neuropathy peripheral  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Paraesthesia  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Parkinson's disease  1  2/2119 (0.09%)  2 0/2114 (0.00%)  0
Radiculopathy  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Sciatica  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Seizure  1  0/2119 (0.00%)  0 5/2114 (0.24%)  5
Sensory disturbance  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Spinal cord compression  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Status epilepticus  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Subdural hygroma  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Syncope  1  2/2119 (0.09%)  2 3/2114 (0.14%)  3
Transient ischaemic attack  1  0/2119 (0.00%)  0 2/2114 (0.09%)  2
Trigeminal neuralgia  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
VIth nerve paralysis  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Vascular dementia  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Vertebral artery dissection  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Vocal cord paralysis  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Pregnancy, puerperium and perinatal conditions     
Abortion missed  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Abortion spontaneous  1  0/2119 (0.00%)  0 2/2114 (0.09%)  2
Unintended pregnancy  1  3/2119 (0.14%)  3 3/2114 (0.14%)  3
Unwanted pregnancy  1  2/2119 (0.09%)  2 2/2114 (0.09%)  2
Product Issues     
Device dislocation  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Psychiatric disorders     
Alcohol withdrawal syndrome  1  0/2119 (0.00%)  0 2/2114 (0.09%)  3
Alcoholism  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Antisocial personality disorder  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Bipolar disorder  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Confusional state  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Delusion  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Depressed mood  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Depression  1  2/2119 (0.09%)  2 4/2114 (0.19%)  4
Depression suicidal  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Eating disorder  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Hypomania  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Persistent depressive disorder  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Post-traumatic stress disorder  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Psychotic disorder  1  1/2119 (0.05%)  1 2/2114 (0.09%)  2
Schizoaffective disorder  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Suicidal ideation  1  2/2119 (0.09%)  2 3/2114 (0.14%)  3
Suicide attempt  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Renal and urinary disorders     
Acute kidney injury  1  9/2119 (0.42%)  9 6/2114 (0.28%)  6
Chronic kidney disease  1  5/2119 (0.24%)  5 3/2114 (0.14%)  3
Haematuria  1  2/2119 (0.09%)  2 1/2114 (0.05%)  1
Hydronephrosis  1  0/2119 (0.00%)  0 2/2114 (0.09%)  2
Loin pain haematuria syndrome  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Nephrolithiasis  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Renal colic  1  1/2119 (0.05%)  1 2/2114 (0.09%)  2
Renal impairment  1  3/2119 (0.14%)  3 3/2114 (0.14%)  3
Ureteric obstruction  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Urinary retention  1  4/2119 (0.19%)  4 2/2114 (0.09%)  2
Reproductive system and breast disorders     
Menorrhagia  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Oedema genital  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Ovarian cyst  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Ovarian cyst torsion  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Pelvic pain  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Prostatitis  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Uterine haemorrhage  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Asthma  1  30/2119 (1.42%)  34 24/2114 (1.14%)  30
Atelectasis  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Bronchiectasis  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Chronic obstructive pulmonary disease  1  5/2119 (0.24%)  6 1/2114 (0.05%)  1
Emphysema  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Epistaxis  1  3/2119 (0.14%)  3 1/2114 (0.05%)  1
Interstitial lung disease  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Pharyngeal inflammation  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Pickwickian syndrome  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Pleurisy  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Pneumonia aspiration  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Pulmonary embolism  1  2/2119 (0.09%)  2 2/2114 (0.09%)  2
Pulmonary eosinophilia  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Pulmonary oedema  1  2/2119 (0.09%)  2 0/2114 (0.00%)  0
Reflux laryngitis  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Respiratory arrest  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Respiratory failure  1  2/2119 (0.09%)  2 2/2114 (0.09%)  2
Sleep apnoea syndrome  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Skin and subcutaneous tissue disorders     
Decubitus ulcer  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Dermatitis  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Eczema  1  2/2119 (0.09%)  2 1/2114 (0.05%)  1
Rash  1  0/2119 (0.00%)  0 3/2114 (0.14%)  3
Skin necrosis  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Skin ulcer  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Surgical and medical procedures     
Abortion induced  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Vascular disorders     
Angiodysplasia  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Aortic stenosis  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Circulatory collapse  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Deep vein thrombosis  1  2/2119 (0.09%)  2 5/2114 (0.24%)  6
Essential hypertension  1  1/2119 (0.05%)  1 1/2114 (0.05%)  1
Haematoma  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Hypertension  1  2/2119 (0.09%)  2 0/2114 (0.00%)  0
Hypotension  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Raynaud's phenomenon  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
Superior vena cava occlusion  1  0/2119 (0.00%)  0 1/2114 (0.05%)  1
Temporal arteritis  1  1/2119 (0.05%)  1 0/2114 (0.00%)  0
1
Term from vocabulary, MedDRA 19.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Usual Care FF/VI
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2119 (0.00%)      0/2114 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01706198    
Other Study ID Numbers: 115150
First Submitted: October 4, 2012
First Posted: October 15, 2012
Results First Submitted: December 6, 2017
Results First Posted: January 24, 2019
Last Update Posted: January 24, 2019