Trial Outcomes & Findings for Phase 2a, AMP Challenge, Dose Escalation Study to Assess the Dose Response for Topical Efficacy and Systemic Activity in Asthmatic Subjects (NCT NCT02991859)
NCT ID: NCT02991859
Last Updated: 2020-07-31
Results Overview
The percentage fall in FEV1 was calculated using highest FEV1 (post saline) minus highest FEV1 (post AMP) divided by highest FEV1 (post saline)\*100 where highest FEV1 (post saline) is the highest value of two FEV1 measurements at 60 and 180 seconds after the saline control, highest FEV1 (post AMP) is the highest value of the two FEV1 measurements at 60 and 180 seconds after the dose of AMP. Results are presented treatment wise. The analysis method was a 3 parameter Emax model with log 2 transformed AMP PC20 as the outcome variable, assuming common Emax across FF, FP and BUD, and with an unstructured variance-covariance matrix. Mean and 95% Confidence Interval (CI) presented are predicted estimate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
12 hours post last dose on Day 7
Results posted on
2020-07-31
Participant Flow
A total of 56 participants were enrolled across 1 center in Germany and 2 centers in the United Kingdom.
A total of 165 participants were screened of which 109 failed screening and 56 participants were enrolled in study. Of the 56 participants enrolled,only 54 were randomized and received at least one dose of study medication. Only 7 participants were withdrawn from the study, 2 participants who were not withdrawn, entered Period 2 esc Phase 1.
Participant milestones
| Measure |
Arm AB - FF Followed by FP
Participants received evening (PM) dose of 1 puff of Fluticasone Furoate (FF) 25 microgram (mcg) (Total daily dose \[TDD\] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by morning (AM) and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.
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Arm AC - FF Followed by BUD
Participants received PM dose of 1 puff of FF 25mcg (TDD=25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD=100 mcg) in second phase; PM dose of 1 puff of FF 200mcg (TDD=200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD =800 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase. Washout period was of 25-42 days.
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Arm AD - FF Followed by ELLIPTA Placebo
Participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phases followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. Washout period was of 25-42 days.
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Arm BA - FP Followed by FF
Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.
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Arm BC - FP Followed by BUD
Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD = 400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period was of 25-42 days.
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Arm BE - FP Followed by DISKUS Placebo
Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. Washout period was of 25-42 days.
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Arm CA - BUD Followed by FF
Participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.
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Arm CB - BUD Followed by FP
Participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD =500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.
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Arm CE - BUD Followed by DISKUS Placebo
Participants received PM dose of 1 puff of BUD as 100 mcg in first phase followed by BUD 200 mcg 1 puff AM and PM (TDD=400 mcg), in third phase BUD 400 mcg 1 puff AM and PM (TDD=800 mcg) followed by BUD 400 mcg 2 puffs AM and PM(TDD=1600mcg) in fourth phase followed by BUD 400 mcg 4puffs AM and PM (TDD=3200mcg) in TP1. In TP 2 participants received DISKUS placebo 1 puff PM in first phase followed by DISKUS placebo 1 puff AM and PM in second phase followed by DISKUS placebo 1 puff AM and PM in third phase followed by DISKUS placebo 1 puff AM and PM in fourth phase followed by DISKUS placebo 2 puffs AM and PM in fifth phase. Washout period was of 25-42 days.
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Arm DA - ELLIPTA Placebo Followed by FF
Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phase followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. In TP 2, participants will receive PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.
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EB - DISKUS Placebo Followed by FP
Participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each of DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.
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Arm DC - ELLIPTA Placebo Followed by BUD
Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phase followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. In TP 2, participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period was of 25-42 days.
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Fluticasone Furoate (FF)
Participants received evening (PM) dose of 1 puff of FF 25 microgram (mcg) (Total daily dose \[TDD\] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase.
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Fluticasone Propionate (FP)
Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by morning (AM) and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase.
|
Budesonide (BUD)
Participants received PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase.
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ELLIPTA
Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phases followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase.
|
DISKUS
Participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase.
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Period 1,Escalation Phase 1,Upto Day 7
STARTED
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Period 1,Escalation Phase 1,Upto Day 7
COMPLETED
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Period 1,Escalation Phase 1,Upto Day 7
NOT COMPLETED
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Period 1,Escalation Phase2,Upto Day 14
STARTED
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Period 1,Escalation Phase2,Upto Day 14
COMPLETED
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Period 1,Escalation Phase2,Upto Day 14
NOT COMPLETED
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Period1, Escalation Phase3, Upto Day21
STARTED
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Period1, Escalation Phase3, Upto Day21
COMPLETED
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Period1, Escalation Phase3, Upto Day21
NOT COMPLETED
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Period1, Escalation Phase4, Upto Day28
STARTED
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Period1, Escalation Phase4, Upto Day28
COMPLETED
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Period1, Escalation Phase4, Upto Day28
NOT COMPLETED
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Period1, Escalation Phase5, Upto Day35
STARTED
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Period1, Escalation Phase5, Upto Day35
COMPLETED
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Period1, Escalation Phase5, Upto Day35
NOT COMPLETED
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Wash Out, Up to Day 77
STARTED
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Wash Out, Up to Day 77
COMPLETED
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Wash Out, Up to Day 77
NOT COMPLETED
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Period2, Escalation Phase1, Upto Day 84
STARTED
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Period2, Escalation Phase1, Upto Day 84
COMPLETED
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Period2, Escalation Phase1, Upto Day 84
NOT COMPLETED
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Period2, Escalation Phase2, Upto Day 91
STARTED
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Period2, Escalation Phase2, Upto Day 91
COMPLETED
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Period2, Escalation Phase2, Upto Day 91
NOT COMPLETED
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Period2, Escalation Phase3, Upto Day 98
STARTED
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Period2, Escalation Phase3, Upto Day 98
COMPLETED
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Period2, Escalation Phase3, Upto Day 98
NOT COMPLETED
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Period2, Escalation Phase4, Upto Day 105
STARTED
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Period2, Escalation Phase4, Upto Day 105
COMPLETED
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Period2, Escalation Phase4, Upto Day 105
NOT COMPLETED
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Period2,Escalation Phase5,Upto Day 112
STARTED
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Period2,Escalation Phase5,Upto Day 112
COMPLETED
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Period2,Escalation Phase5,Upto Day 112
NOT COMPLETED
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0
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0
|
0
|
Reasons for withdrawal
| Measure |
Arm AB - FF Followed by FP
Participants received evening (PM) dose of 1 puff of Fluticasone Furoate (FF) 25 microgram (mcg) (Total daily dose \[TDD\] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by morning (AM) and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.
|
Arm AC - FF Followed by BUD
Participants received PM dose of 1 puff of FF 25mcg (TDD=25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD=100 mcg) in second phase; PM dose of 1 puff of FF 200mcg (TDD=200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD =800 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase. Washout period was of 25-42 days.
|
Arm AD - FF Followed by ELLIPTA Placebo
Participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phases followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. Washout period was of 25-42 days.
|
Arm BA - FP Followed by FF
Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.
|
Arm BC - FP Followed by BUD
Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD = 400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period was of 25-42 days.
|
Arm BE - FP Followed by DISKUS Placebo
Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. Washout period was of 25-42 days.
|
Arm CA - BUD Followed by FF
Participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.
|
Arm CB - BUD Followed by FP
Participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD =500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.
|
Arm CE - BUD Followed by DISKUS Placebo
Participants received PM dose of 1 puff of BUD as 100 mcg in first phase followed by BUD 200 mcg 1 puff AM and PM (TDD=400 mcg), in third phase BUD 400 mcg 1 puff AM and PM (TDD=800 mcg) followed by BUD 400 mcg 2 puffs AM and PM(TDD=1600mcg) in fourth phase followed by BUD 400 mcg 4puffs AM and PM (TDD=3200mcg) in TP1. In TP 2 participants received DISKUS placebo 1 puff PM in first phase followed by DISKUS placebo 1 puff AM and PM in second phase followed by DISKUS placebo 1 puff AM and PM in third phase followed by DISKUS placebo 1 puff AM and PM in fourth phase followed by DISKUS placebo 2 puffs AM and PM in fifth phase. Washout period was of 25-42 days.
|
Arm DA - ELLIPTA Placebo Followed by FF
Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phase followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. In TP 2, participants will receive PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.
|
EB - DISKUS Placebo Followed by FP
Participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each of DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.
|
Arm DC - ELLIPTA Placebo Followed by BUD
Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phase followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. In TP 2, participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period was of 25-42 days.
|
Fluticasone Furoate (FF)
Participants received evening (PM) dose of 1 puff of FF 25 microgram (mcg) (Total daily dose \[TDD\] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase.
|
Fluticasone Propionate (FP)
Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by morning (AM) and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase.
|
Budesonide (BUD)
Participants received PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase.
|
ELLIPTA
Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phases followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase.
|
DISKUS
Participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Period 1,Escalation Phase 1,Upto Day 7
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period1, Escalation Phase3, Upto Day21
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Wash Out, Up to Day 77
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Wash Out, Up to Day 77
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Period2, Escalation Phase4, Upto Day 105
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Phase 2a, AMP Challenge, Dose Escalation Study to Assess the Dose Response for Topical Efficacy and Systemic Activity in Asthmatic Subjects
Baseline characteristics by cohort
| Measure |
Arm AB - FF Followed by FP
n=2 Participants
Participants received evening (PM) dose of 1 puff of Fluticasone Furoate (FF) 25 microgram (mcg) (Total daily dose \[TDD\] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by morning (AM) and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.
|
AC - FF Followed by BUD
n=3 Participants
Participants will receive PM dose of 1 puff of FF 25mcg (TDD=25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD=100 mcg) in second phase; PM dose of 1 puff of FF 200mcg (TDD=200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD =800 mcg) in fifth phase. In TP 2, participants will receive PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase. Washout period will be of 25-42 days
|
Arm AD - FF Followed by ELLIPTA Placebo
n=2 Participants
Participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phases followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. Washout period was of 25-42 days.
|
Arm BA - FP Followed by FF
n=2 Participants
Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.
|
Arm BC - FP Followed by BUD
n=3 Participants
Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD = 400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period was of 25-42 days.
|
Arm BE - FP Followed by DISKUS Placebo
n=3 Participants
Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. Washout period was of 25-42 days.
|
Arm CA - BUD Followed by FF
n=2 Participants
Participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.
|
Arm CB - BUD Followed by FP
n=2 Participants
Participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD =500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.
|
Arm CE - BUD Followed by DISKUS Placebo
n=2 Participants
Participants received PM dose of 1 puff of BUD as 100 mcg in first phase followed by BUD 200 mcg 1 puff AM and PM (TDD=400 mcg), in third phase BUD 400 mcg 1 puff AM and PM (TDD=800 mcg) followed by BUD 400 mcg 2 puffs AM and PM(TDD=1600mcg) in fourth phase followed by BUD 400 mcg 4puffs AM and PM (TDD=3200mcg) in TP1. In TP 2 participants received DISKUS placebo 1 puff PM in first phase followed by DISKUS placebo 1 puff AM and PM in second phase followed by DISKUS placebo 1 puff AM and PM in third phase followed by DISKUS placebo 1 puff AM and PM in fourth phase followed by DISKUS placebo 2 puffs AM and PM in fifth phase. Washout period was of 25-42 days.
|
Arm DA - ELLIPTA Placebo Followed by FF
n=3 Participants
Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phase followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. In TP 2, participants will receive PM dose of 1 puff of FF 25 mcg (TDD = 25 mcg) in first phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puffs of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puffs of FF 200 mcg (TDD = 800 mcg) in fifth phase. Washout period was of 25-42 days.
|
EB - DISKUS Placebo Followed by FP
n=2 Participants
Participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each of DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase. In TP 2, participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by AM and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase. Washout period was of 25-42 days.
|
Arm DC - ELLIPTA Placebo Followed by BUD
n=2 Participants
Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phase followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase. In TP 2, participants received PM dose of 1 puff of BUD 100 mcg (TDD =100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD =400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD = 800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD =1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD = 3200 mcg) in fifth phase. Washout period was of 25-42 days.
|
Fluticasone Furoate (FF)
n=7 Participants
Participants received evening (PM) dose of 1 puff of FF 25 microgram (mcg) (Total daily dose \[TDD\] = 25 mcg) in first dose escalation phase followed by PM dose of 1 puff of FF 100 mcg (TDD = 100 mcg) in second phase; PM dose of 1 puff of FF 200 mcg (TDD = 200 mcg) in third phase; PM dose of 2 puff of FF 200 mcg (TDD = 400 mcg) in fourth phase and PM dose of 4 puff of FF 200 mcg (TDD = 800 mcg) in fifth phase.
|
Fluticasone Propionate (FP)
n=7 Participants
Participants received PM dose of 1 puff of FP 50 mcg (TDD = 50 mcg) in first phase followed by morning (AM) and PM doses of 1 puff each of FP 100 mcg (TDD = 200 mcg) in second phase; AM and PM doses of 1 puff each of FP 250 mcg (TDD = 500 mcg) in third phase; AM and PM doses of 1 puff each of FP 500 mcg (TDD = 1000 mcg) in fourth phase and AM and PM doses of 2 puffs each of FP 500 mcg (TDD = 2000 mcg) in fifth phase.
|
Budesonide (BUD)
n=6 Participants
Participants received PM dose of 1 puff of BUD 100 mcg (TDD=100 mcg) in first phase followed by AM and PM doses of 1 puff each of BUD 200 mcg (TDD=400 mcg) in second phase; AM and PM doses of 1 puff each of BUD 400 mcg (TDD=800 mcg) in third phase; AM and PM doses of 2 puffs each of BUD 400 mcg (TDD=1600 mcg) in fourth phase and AM and PM doses of 4 puffs each of BUD 400 mcg (TDD=3200 mcg) in fifth phase.
|
ELLIPTA
n=3 Participants
Participants received PM dose of 1 puff of ELLIPTA Placebo in first, second and third phases followed by PM dose of 2 puffs of ELLIPTA Placebo in fourth phase and PM dose of 4 puffs of ELLIPTA Placebo in fifth phase.
|
DISKUS
n=3 Participants
Participants received PM dose of 1 puff of DISKUS Placebo in first phase followed by AM and PM doses of 1 puff each DISKUS Placebo in second, third and fourth phase; AM and PM doses of 2 puffs each of DISKUS Placebo in fifth phase.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
3 Participants
n=44 Participants
|
|
Age, Customized
18 to 64 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
7 Participants
n=36 Participants
|
7 Participants
n=36 Participants
|
5 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
50 Participants
n=44 Participants
|
|
Age, Customized
65 to 84 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
3 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
13 Participants
n=44 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
4 Participants
n=36 Participants
|
5 Participants
n=24 Participants
|
3 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
41 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
ASIAN - CENTRAL/SOUTH ASIAN HERITAGE
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
4 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
ASIAN - EAST ASIAN HERITAGE
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
AFRICAN AMERICAN/AFRICAN HERITAGE
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
7 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
WHITE - ARABIC/NORTH AFRICAN HERITAGE
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
MULTIPLE
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
2 Participants
n=44 Participants
|
|
Race/Ethnicity, Customized
WHITE - WHITE/CAUCASIAN/EUROPEAN HERITAGE
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
5 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
4 Participants
n=24 Participants
|
2 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
39 Participants
n=44 Participants
|
PRIMARY outcome
Timeframe: 12 hours post last dose on Day 7Population: Pharmacodymanic (PD) population. Participants who were randomized and received at least one dose of trial medication and also have at least one post dose PD measurement. Only those participants with data available at the specified time points were analyzed.
The percentage fall in FEV1 was calculated using highest FEV1 (post saline) minus highest FEV1 (post AMP) divided by highest FEV1 (post saline)\*100 where highest FEV1 (post saline) is the highest value of two FEV1 measurements at 60 and 180 seconds after the saline control, highest FEV1 (post AMP) is the highest value of the two FEV1 measurements at 60 and 180 seconds after the dose of AMP. Results are presented treatment wise. The analysis method was a 3 parameter Emax model with log 2 transformed AMP PC20 as the outcome variable, assuming common Emax across FF, FP and BUD, and with an unstructured variance-covariance matrix. Mean and 95% Confidence Interval (CI) presented are predicted estimate.
Outcome measures
| Measure |
FF 25 mcg
n=19 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
n=19 Participants
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
n=18 Participants
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
n=18 Participants
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
n=17 Participants
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
n=20 Participants
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
n=20 Participants
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
n=18 Participants
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
n=16 Participants
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
n=17 Participants
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
n=18 Participants
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
n=18 Participants
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
n=18 Participants
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
n=18 Participants
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
n=17 Participants
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Provocative Concentration (PC) of Adenosine 5' Monophosphate (AMP) Causing a 20 Percent (%) Reduction in Forced Expiratory Volume in 1 Second (FEV1) (AMP PC20)- Dose Response Analysis
|
33.45 Milligrams per milliliter
Interval 19.1 to 58.6
|
81.45 Milligrams per milliliter
Interval 44.65 to 148.58
|
115.69 Milligrams per milliliter
Interval 66.82 to 200.31
|
145.97 Milligrams per milliliter
Interval 85.02 to 250.59
|
167.26 Milligrams per milliliter
Interval 95.36 to 293.37
|
15.19 Milligrams per milliliter
Interval 10.8 to 21.36
|
20.47 Milligrams per milliliter
Interval 13.94 to 30.07
|
31.39 Milligrams per milliliter
Interval 18.88 to 52.19
|
48.67 Milligrams per milliliter
Interval 27.3 to 86.78
|
76.35 Milligrams per milliliter
Interval 43.21 to 134.91
|
16.00 Milligrams per milliliter
Interval 11.41 to 22.44
|
23.91 Milligrams per milliliter
Interval 15.08 to 37.9
|
34.62 Milligrams per milliliter
Interval 19.28 to 62.16
|
54.33 Milligrams per milliliter
Interval 28.4 to 103.93
|
84.17 Milligrams per milliliter
Interval 45.48 to 155.79
|
—
|
PRIMARY outcome
Timeframe: Pre-dose PM dose on Day 6 to pre-dose PM dose Day 7Population: PD population. Only those participants with data available for each dose escalation phase were analyzed.
Blood samples for measurement of plasma cortisol were collected at given time point. The weighted means were derived by calculating the area under the curve (AUC) over the 0-24-hour period using the trapezoidal rule, and then dividing it by the actual time interval. Results are presented treatment wise. Mean and 95% CI presented are predicted estimate. The analysis method was an inhibitory exponential power-law model with log e transformed cortisol as the outcome variable, assuming 100% inhibition at highest doses.
Outcome measures
| Measure |
FF 25 mcg
n=19 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
n=19 Participants
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
n=18 Participants
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
n=18 Participants
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
n=18 Participants
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
n=20 Participants
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
n=19 Participants
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
n=18 Participants
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
n=16 Participants
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
n=16 Participants
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
n=16 Participants
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
n=16 Participants
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
n=18 Participants
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
n=18 Participants
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
n=17 Participants
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cortisol Suppression 0-24 Hours Weighted Mean-Dose Response Analysis
|
172.73 nanomoles per liter
Interval 159.88 to 186.62
|
163.03 nanomoles per liter
Interval 151.01 to 176.02
|
150.95 nanomoles per liter
Interval 139.48 to 163.37
|
129.40 nanomoles per liter
Interval 117.82 to 142.12
|
95.09 nanomoles per liter
Interval 82.26 to 109.93
|
173.04 nanomoles per liter
Interval 160.15 to 186.97
|
164.22 nanomoles per liter
Interval 152.11 to 177.29
|
147.89 nanomoles per liter
Interval 136.59 to 160.13
|
124.21 nanomoles per liter
Interval 112.88 to 136.68
|
87.62 nanomoles per liter
Interval 75.37 to 101.85
|
169.87 nanomoles per liter
Interval 157.23 to 183.52
|
152.50 nanomoles per liter
Interval 141.26 to 164.63
|
132.06 nanomoles per liter
Interval 122.05 to 142.9
|
99.05 nanomoles per liter
Interval 90.24 to 108.72
|
55.71 nanomoles per liter
Interval 48.26 to 64.31
|
—
|
PRIMARY outcome
Timeframe: 12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7Population: PD population. Only those participants with data available at the specified time points were analyzed.
Therapeutic Index was calculated by ED20 for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter\[nmol/L\]) divided by Dose at which 80% of the maximum effect is reached (ED80) for AMP PC20 for FF 25 mcg, FF 100 mcg, FF 200 mcg, FF 400 mcg, FF 800 mcg. Theraputic index has been presented. Only those participants with data available at the specified time points were analyzed. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively.
Outcome measures
| Measure |
FF 25 mcg
n=51 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Theraputic Index of FF
|
1.49 Ratio
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7Population: PD population. Only those participants with data available at the specified time points were analyzed.
Therapeutic Index was calculated by Dose at which 20% of the maximum effect is reached (ED20) for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter\[nmol/L\]) divided by ED80 for AMP PC20 for FP 50 mcg, FP 200 mcg, FP 500 mcg, FP 1000 mcg, FP 2000 mcg. Theraputic index has been presented. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively.
Outcome measures
| Measure |
FF 25 mcg
n=51 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Theraputic Index of FP
|
0.15 Ratio
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 hours post-dose on Day 7, pre-dose PM dose on Day 6 to pre-dose PM dose Day 7Population: PD population. Only those participants with data available at the specified time points were analyzed.
Therapeutic Index was calculated by ED20 for Cortisol Suppression 0-24 Hours Weighted Mean (nanomoles per liter\[nmol/L\]) divided by ED80 for AMP PC20 for BUD 100 mcg, BUD 400 mcg, BUD 800 mcg, BUD 1600 mcg, BUD 3200 mcg. Theraputic index has been presented. The timeframe mentioned is for AMP PC20 and Cortisol suppression respectively.
Outcome measures
| Measure |
FF 25 mcg
n=51 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Theraputic Index of BUD
|
0.11 Ratio
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to Week 18Population: All Subjects Population was consisted of all participants who were randomized and who received at least one dose of trial medication.
An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=17 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
n=20 Participants
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
n=19 Participants
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
n=19 Participants
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
n=18 Participants
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
n=18 Participants
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
n=21 Participants
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
n=20 Participants
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
n=20 Participants
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
n=18 Participants
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
n=17 Participants
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
n=18 Participants
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
n=18 Participants
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
n=18 Participants
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
n=18 Participants
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
n=18 Participants
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)
Any AEs
|
10 Participants
|
6 Participants
|
8 Participants
|
7 Participants
|
6 Participants
|
7 Participants
|
10 Participants
|
4 Participants
|
4 Participants
|
8 Participants
|
6 Participants
|
6 Participants
|
8 Participants
|
5 Participants
|
6 Participants
|
3 Participants
|
|
Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Event (SAE)
Any SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 2 to 8 PM, Day 9 to 14 AM and PM, Day 15 PM, Day 16 to 21 AM and PM, Day 22 PM,Day 23 to 28 AM and PM, Day 29 PM,Day 30 to 35 AM and PM in period 1Population: All subjects Population.
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Participants recorded their PEFR measurement before each dose in a paper diary. Results are presented treatment wise.Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
Outcome measures
| Measure |
FF 25 mcg
n=12 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 23,PM, n=11
|
530.0 Liters per minute
Standard Error 27.4
|
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—
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 24, AM, n=4
|
567.5 Liters per minute
Standard Error 39.4
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 24,PM, n=11
|
526.4 Liters per minute
Standard Error 26.5
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 25, AM, n=4
|
585.0 Liters per minute
Standard Error 39.2
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 25,PM, n=11
|
530.9 Liters per minute
Standard Error 29.6
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 26, AM, n=4
|
582.5 Liters per minute
Standard Error 40.0
|
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—
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 26,PM, n=11
|
518.2 Liters per minute
Standard Error 30.0
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 27, AM, n=4
|
587.5 Liters per minute
Standard Error 40.0
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 27,PM, n=11
|
539.1 Liters per minute
Standard Error 29.3
|
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—
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 28, AM, n=4
|
587.5 Liters per minute
Standard Error 43.0
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 28,PM, n=10
|
547.0 Liters per minute
Standard Error 30.4
|
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—
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 29,PM, n=11
|
547.3 Liters per minute
Standard Error 28.2
|
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—
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—
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|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 30, AM, n=4
|
567.5 Liters per minute
Standard Error 38.1
|
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—
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—
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—
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|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 30,PM, n=11
|
527.3 Liters per minute
Standard Error 26.6
|
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—
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—
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—
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 31, AM, n=4
|
562.5 Liters per minute
Standard Error 33.2
|
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—
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—
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—
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—
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 31,PM, n=11
|
537.3 Liters per minute
Standard Error 26.5
|
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—
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—
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 32, AM, n=4
|
582.5 Liters per minute
Standard Error 40.2
|
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—
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—
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|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 32,PM, n=11
|
537.3 Liters per minute
Standard Error 26.2
|
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—
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 33, AM, n=4
|
597.5 Liters per minute
Standard Error 40.0
|
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—
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 33,PM, n=11
|
528.2 Liters per minute
Standard Error 30.5
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 34, AM, n=4
|
580.0 Liters per minute
Standard Error 39.3
|
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—
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 34,PM, n=11
|
531.4 Liters per minute
Standard Error 31.9
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 35, AM, n=4
|
565.0 Liters per minute
Standard Error 38.8
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 35,PM, n=11
|
501.8 Liters per minute
Standard Error 26.1
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 2, PM, n=12
|
522.5 Liters per minute
Standard Error 25.4
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 3, PM, n=12
|
517.5 Liters per minute
Standard Error 27.0
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 4, PM, n=12
|
514.2 Liters per minute
Standard Error 27.8
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 5,PM, n=12
|
521.7 Liters per minute
Standard Error 24.2
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 6, PM, n=12
|
522.5 Liters per minute
Standard Error 29.1
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 7, PM, n=12
|
539.2 Liters per minute
Standard Error 32.3
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 8, PM, n=12
|
530.8 Liters per minute
Standard Error 27.8
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 9, AM, n=5
|
576.0 Liters per minute
Standard Error 37.5
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 9, PM, n=12
|
531.3 Liters per minute
Standard Error 27.9
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 10, AM, n=5
|
572.0 Liters per minute
Standard Error 34.4
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 10, PM, n=12
|
535.0 Liters per minute
Standard Error 22.0
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 11, AM, n=5
|
578.0 Liters per minute
Standard Error 35.9
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 11, PM, n=12
|
533.8 Liters per minute
Standard Error 29.0
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 12, AM, n=5
|
578.0 Liters per minute
Standard Error 37.2
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 12 PM, n=12
|
527.5 Liters per minute
Standard Error 26.7
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 13, AM, n=5
|
580.0 Liters per minute
Standard Error 37.4
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 13, PM, n=12
|
540.8 Liters per minute
Standard Error 25.1
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 14, AM, n=5
|
572.0 Liters per minute
Standard Error 34.7
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 14, PM, n=12
|
543.3 Liters per minute
Standard Error 26.4
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 15, PM, n=12
|
530.8 Liters per minute
Standard Error 26.0
|
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 16, AM, n=5
|
588.0 Liters per minute
Standard Error 36.1
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 16,PM, n=12
|
528.3 Liters per minute
Standard Error 24.4
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 17, AM, n=5
|
586.0 Liters per minute
Standard Error 31.7
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 17,PM, n=12
|
521.7 Liters per minute
Standard Error 32.5
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 18, AM, n=5
|
586.0 Liters per minute
Standard Error 35.0
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 18,PM, n=12
|
540.0 Liters per minute
Standard Error 26.9
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 19, AM, n=5
|
568.0 Liters per minute
Standard Error 38.3
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 19,PM, n=12
|
535.8 Liters per minute
Standard Error 29.3
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 20, AM, n=5
|
596.0 Liters per minute
Standard Error 37.5
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 20,PM, n=12
|
544.2 Liters per minute
Standard Error 28.2
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 21, AM, n=5
|
580.0 Liters per minute
Standard Error 31.4
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 21,PM, n=12
|
534.2 Liters per minute
Standard Error 32.6
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 22,PM, n=11
|
544.5 Liters per minute
Standard Error 29.0
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Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability of Placebo in Period 1
Day 23, AM, n=4
|
577.5 Liters per minute
Standard Error 37.9
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SECONDARY outcome
Timeframe: Day 2 to 8 PM, Day 9 to 14 AM and PM, Day 15 PM, Day 16 to 21 AM and PM, Day 22 PM,Day 23 to 28 AM and PM, Day 29 PM,Day 30 to 35 AM and PM in Period 2Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Participants recorded their PEFR measurement before each dose in a paper diary. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=4 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
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FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
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FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
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FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
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FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
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FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
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FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
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FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
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FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
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FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
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BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
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BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
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BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
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BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
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BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
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BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 2, PM, n=4
|
422.5 Liters per minute
Standard Error 28.9
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 3, PM, n=4
|
415.0 Liters per minute
Standard Error 27.2
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 4, PM, n=4
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398.8 Liters per minute
Standard Error 26.6
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 5,PM, n=4
|
407.5 Liters per minute
Standard Error 37.5
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 6, PM, n=4
|
411.3 Liters per minute
Standard Error 29.0
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 7, PM, n=4
|
410.0 Liters per minute
Standard Error 36.7
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 8, PM, n=4
|
415.0 Liters per minute
Standard Error 36.1
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 9, AM, n=2
|
430.0 Liters per minute
Standard Error 80.0
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 9, PM, n=4
|
411.3 Liters per minute
Standard Error 45.4
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 10, AM, n=2
|
425.0 Liters per minute
Standard Error 65.0
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 10, PM, n=4
|
403.8 Liters per minute
Standard Error 37.1
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 11, AM, n=2
|
410.0 Liters per minute
Standard Error 60.0
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 11, PM, n=4
|
395.0 Liters per minute
Standard Error 29.0
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 12, AM, n=2
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400.0 Liters per minute
Standard Error 50.0
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 12, PM, n=4
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398.8 Liters per minute
Standard Error 28.6
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 13, AM, n=2
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415.0 Liters per minute
Standard Error 95.0
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 13, PM, n=4
|
425.0 Liters per minute
Standard Error 35.2
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 14, AM, n=2
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425.0 Liters per minute
Standard Error 65.0
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 14, PM, n=3
|
420.0 Liters per minute
Standard Error 40.4
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 15, PM, n=4
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416.3 Liters per minute
Standard Error 37.0
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 16, AM, n=2
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405.0 Liters per minute
Standard Error 75.0
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 16,PM, n=4
|
405.0 Liters per minute
Standard Error 32.0
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 17, AM, n=2
|
390.0 Liters per minute
Standard Error 70.0
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 17,PM, n=4
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405.0 Liters per minute
Standard Error 28.9
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 18, AM, n=1
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450.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 18,PM,n=3
|
423.3 Liters per minute
Standard Error 34.8
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 19, AM, n=2
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415.0 Liters per minute
Standard Error 65.0
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 19,PM, n=4
|
402.5 Liters per minute
Standard Error 30.1
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 20, AM, n=2
|
402.5 Liters per minute
Standard Error 57.5
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 20,PM, n=4
|
398.8 Liters per minute
Standard Error 36.3
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 21, AM, n=2
|
400.0 Liters per minute
Standard Error 60.0
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 21,PM, n=4
|
395.0 Liters per minute
Standard Error 38.6
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 22,PM, n=4
|
397.5 Liters per minute
Standard Error 34.9
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 23, AM, n=1
|
480.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 23,PM, n=3
|
415.0 Liters per minute
Standard Error 39.0
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 24, AM, n=1
|
460.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
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PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 24,PM, n=3
|
423.3 Liters per minute
Standard Error 38.4
|
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—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 25, AM, n=1
|
460.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 25,PM, n=3
|
416.7 Liters per minute
Standard Error 33.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 26, AM, n=1
|
450.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 26,PM, n=3
|
418.3 Liters per minute
Standard Error 36.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 27, AM, n=1
|
460.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 27,PM, n=3
|
433.3 Liters per minute
Standard Error 49.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 28, AM, n=1
|
460.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 28,PM, n=3
|
430.0 Liters per minute
Standard Error 49.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 29,PM, n=3
|
380.0 Liters per minute
Standard Error 75.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 30, AM, n=1
|
460.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 30,PM, n=3
|
388.3 Liters per minute
Standard Error 78.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 31, AM, n=1
|
480.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 31,PM, n=3
|
390.0 Liters per minute
Standard Error 85.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 32, AM, n=1
|
500.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 32,PM, n=3
|
370.0 Liters per minute
Standard Error 73.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 33, AM, n=1
|
470.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 33,PM, n=3
|
370.0 Liters per minute
Standard Error 70.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 34, AM, n=1
|
460.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 34,PM, n=3
|
390.0 Liters per minute
Standard Error 83.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 35, AM, n=1
|
480.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability of Placebo in Period 2
Day 35,PM, n=2
|
345.0 Liters per minute
Standard Error 105.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 2,3,4,5,6,7 PM in period 1Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=14 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 1
Day 2, PM, n=14
|
479.6 Liters per minute
Standard Error 30.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 1
Day 3, PM, n=14
|
475.7 Liters per minute
Standard Error 32.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 1
Day 4, PM, n=14
|
473.0 Liters per minute
Standard Error 31.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 1
Day 5,PM, n=14
|
476.1 Liters per minute
Standard Error 26.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 1
Day 6, PM, n=13
|
503.1 Liters per minute
Standard Error 24.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 1
Day 7, PM, n=13
|
502.3 Liters per minute
Standard Error 28.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 2,3,4,5,6,7 PM in period 2Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n= X in the category titles).
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=6 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 2
Day 2, PM, n=5
|
572.0 Liters per minute
Standard Error 48.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 2
Day 3, PM, n=5
|
570.0 Liters per minute
Standard Error 54.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 2
Day 4, PM, n=5
|
568.0 Liters per minute
Standard Error 55.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 2
Day 5,PM, n=5
|
573.0 Liters per minute
Standard Error 54.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 2
Day 6, PM, n=6
|
550.8 Liters per minute
Standard Error 52.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 25 mcg in Period 2
Day 7, PM, n=6
|
560.0 Liters per minute
Standard Error 45.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8,9,10,11,12,13,14 PM in period 1Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=13 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 1
Day 8, PM, n=13
|
497.3 Liters per minute
Standard Error 24.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 1
Day 9, PM, n=13
|
500.4 Liters per minute
Standard Error 28.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 1
Day 10, PM, n=13
|
491.2 Liters per minute
Standard Error 31.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 1
Day 11, PM, n=12
|
507.5 Liters per minute
Standard Error 30.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 1
Day 12, PM, n=13
|
500.2 Liters per minute
Standard Error 30.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 1
Day 13, PM, n=13
|
515.4 Liters per minute
Standard Error 29.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 1
Day 14, PM, n=13
|
505.8 Liters per minute
Standard Error 28.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8,9,10,11,12,13,14 PM in period 2Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=6 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 2
Day 8, PM
|
540.0 Liters per minute
Standard Error 43.8
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 2
Day 9, PM
|
567.5 Liters per minute
Standard Error 42.6
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 2
Day 10, PM
|
556.7 Liters per minute
Standard Error 43.4
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
|
—
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—
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—
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—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 2
Day 11, PM
|
561.7 Liters per minute
Standard Error 44.6
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 2
Day 12, PM
|
573.3 Liters per minute
Standard Error 50.0
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 2
Day 13, PM
|
563.3 Liters per minute
Standard Error 53.0
|
—
|
—
|
—
|
—
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—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 100 mcg in Period 2
Day 14, PM
|
555.8 Liters per minute
Standard Error 46.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15,16,17,18,19,20,21 PM in period 1Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=13 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 1
Day 15,PM, n=13
|
500.8 Liters per minute
Standard Error 30.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 1
Day 16,PM, n=13
|
500.0 Liters per minute
Standard Error 28.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 1
Day 17,PM, n=13
|
506.2 Liters per minute
Standard Error 29.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 1
Day 18,PM, n=13
|
514.2 Liters per minute
Standard Error 31.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 1
Day 19,PM, n=13
|
505.4 Liters per minute
Standard Error 29.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 1
Day 20,PM, n=12
|
505.8 Liters per minute
Standard Error 30.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 1
Day 21,PM, n=12
|
485.0 Liters per minute
Standard Error 28.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15,16,17,18,19,20 PM, Day 21 AM and PM in period 2Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=6 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 2
Day 15,PM, n=6
|
575.0 Liters per minute
Standard Error 52.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 2
Day 16,PM, n=6
|
575.0 Liters per minute
Standard Error 48.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 2
Day 17,PM, n=6
|
564.2 Liters per minute
Standard Error 46.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 2
Day 18,PM, n=6
|
573.3 Liters per minute
Standard Error 56.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 2
Day 19,PM, n=6
|
556.7 Liters per minute
Standard Error 53.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 2
Day 20,PM, n=6
|
571.7 Liters per minute
Standard Error 50.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 2
Day 21,AM, n=1
|
670.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 200 mcg in Period 2
Day 21,PM, n=6
|
560.0 Liters per minute
Standard Error 38.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 22,23,24,25,26,27,28 PM in period 1Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed.
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=12 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 1
Day 22 PM
|
496.7 Liters per minute
Standard Error 30.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 1
Day 23 PM
|
481.0 Liters per minute
Standard Error 25.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 1
Day 24 PM
|
484.6 Liters per minute
Standard Error 25.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 1
Day 25 PM
|
488.3 Liters per minute
Standard Error 26.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 1
Day 26 PM
|
496.7 Liters per minute
Standard Error 28.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 1
Day 27 PM
|
508.8 Liters per minute
Standard Error 28.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 1
Day 28 PM
|
486.7 Liters per minute
Standard Error 23.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 22,23,24,25,26,27,28 PM in period 2Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed.
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=6 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 2
Day 22 PM
|
556.7 Liters per minute
Standard Error 46.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 2
Day 23 PM
|
566.7 Liters per minute
Standard Error 47.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 2
Day 24 PM
|
571.7 Liters per minute
Standard Error 50.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 2
Day 25 PM
|
568.3 Liters per minute
Standard Error 52.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 2
Day 26 PM
|
565.0 Liters per minute
Standard Error 43.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 2
Day 27 PM
|
540.0 Liters per minute
Standard Error 43.3
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
|
—
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—
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—
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—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 400 mcg in Period 2
Day 28 PM
|
541.7 Liters per minute
Standard Error 41.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 29,30,31,32,33,34,35 PM in period 1Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed.
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=12 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 1
Day 29 PM
|
496.7 Liters per minute
Standard Error 27.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 1
Day 30 PM
|
487.1 Liters per minute
Standard Error 25.9
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
|
—
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—
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—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 1
Day 31 PM
|
488.3 Liters per minute
Standard Error 24.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 1
Day 32 PM
|
481.3 Liters per minute
Standard Error 25.8
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
|
—
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—
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—
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—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 1
Day 33 PM
|
481.5 Liters per minute
Standard Error 24.9
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 1
Day 34 PM
|
487.5 Liters per minute
Standard Error 28.7
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 1
Day 35 PM
|
471.0 Liters per minute
Standard Error 26.6
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
SECONDARY outcome
Timeframe: Day 29,30,31,32,33,34,35 PM in period 2Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed.
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=6 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 2
Day 29 PM
|
576.7 Liters per minute
Standard Error 44.9
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 2
Day 30 PM
|
560.0 Liters per minute
Standard Error 48.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 2
Day 31 PM
|
553.3 Liters per minute
Standard Error 45.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 2
Day 32 PM
|
565.0 Liters per minute
Standard Error 50.7
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 2
Day 33 PM
|
580.0 Liters per minute
Standard Error 48.9
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 2
Day 34 PM
|
568.3 Liters per minute
Standard Error 42.3
|
—
|
—
|
—
|
—
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—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FF 800 mcg in Period 2
Day 35 PM
|
556.7 Liters per minute
Standard Error 44.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 2,3,4,5,6,7 PM in period 1Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=15 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 1
Day 2 PM, n=15
|
529.3 Liters per minute
Standard Error 28.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 1
Day 3 PM, n=14
|
533.6 Liters per minute
Standard Error 30.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 1
Day 4 PM, n=15
|
532.3 Liters per minute
Standard Error 30.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 1
Day 5 PM, n=15
|
524.0 Liters per minute
Standard Error 29.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 1
Day 6 PM, n=14
|
519.3 Liters per minute
Standard Error 26.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 1
Day 7 PM, n=14
|
502.9 Liters per minute
Standard Error 35.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 2,3,4,5,6,7 AM and PM in period 2Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=6 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 2
Day 2 AM, n=1
|
600.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 2
Day 2 PM, n=6
|
490.0 Liters per minute
Standard Error 40.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 2
Day 3 AM, n=1
|
600.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 2
Day 3 PM, n=6
|
486.7 Liters per minute
Standard Error 42.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 2
Day 4 PM, n=1
|
590.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 2
Day 4 PM, n=6
|
491.7 Liters per minute
Standard Error 42.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 2
Day 5 AM, n=1
|
600.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 2
Day 5 PM, n=6
|
491.7 Liters per minute
Standard Error 44.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 2
Day 6 PM, n=1
|
600.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 2
Day 6 PM, n=6
|
490.0 Liters per minute
Standard Error 44.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 2
Day 7 PM, n=1
|
600.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
PEFR as a Measure of Safety and Tolerability for FP 50 mcg in Period 2
Day 7 PM, n=6
|
466.0 Liters per minute
Standard Error 48.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 8,9,1,0,11,12,13,14 AM and PM in period 1Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=14 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 1
Day14 PM, n=13
|
522.7 Liters per minute
Standard Error 32.9
|
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—
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—
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—
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—
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|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 1
Day 8 AM, n=1
|
540.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
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—
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—
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—
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|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 1
Day 8 PM, n=13
|
532.7 Liters per minute
Standard Error 33.2
|
—
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—
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—
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—
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—
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—
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|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 1
Day 9 AM, n=11
|
500.9 Liters per minute
Standard Error 38.3
|
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|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 1
Day 9 PM, n=14
|
517.9 Liters per minute
Standard Error 26.8
|
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|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 1
Day 10 AM, n=10
|
521.0 Liters per minute
Standard Error 39.0
|
—
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—
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—
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—
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—
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—
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|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 1
Day 10 PM, n=14
|
513.2 Liters per minute
Standard Error 28.5
|
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—
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—
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—
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|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 1
Day 11 AM, n=11
|
476.4 Liters per minute
Standard Error 35.4
|
—
|
—
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—
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—
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—
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—
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—
|
|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 1
Day 11 PM, n=14
|
512.1 Liters per minute
Standard Error 30.0
|
—
|
—
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—
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—
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—
|
|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 1
Day 12 AM, n=11
|
506.8 Liters per minute
Standard Error 38.0
|
—
|
—
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—
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—
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—
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—
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—
|
|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 1
Day 12 PM, n=13
|
528.8 Liters per minute
Standard Error 34.3
|
—
|
—
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—
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—
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—
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—
|
|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 1
Day 13 AM, n=11
|
500.0 Liters per minute
Standard Error 38.2
|
—
|
—
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—
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—
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—
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—
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—
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—
|
|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 1
Day 13 PM, n=14
|
514.6 Liters per minute
Standard Error 31.1
|
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|
—
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—
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—
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—
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—
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—
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—
|
|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 1
Day 14 AM, n=13
|
496.2 Liters per minute
Standard Error 31.7
|
—
|
—
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—
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—
|
SECONDARY outcome
Timeframe: Day 8,9,1,0,11,12,13,14 AM and PM in period 2Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=6 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 2
Day 8 AM, n=1
|
610.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 2
Day 8 PM, n=6
|
500.0 Liters per minute
Standard Error 43.2
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 2
Day 9 AM, n=5
|
506.0 Liters per minute
Standard Error 39.5
|
—
|
—
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—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 2
Day 9 PM, n=6
|
488.3 Liters per minute
Standard Error 43.7
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
|
|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 2
Day 10 PM, n=6
|
490.0 Liters per minute
Standard Error 47.1
|
—
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—
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—
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—
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—
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—
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—
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—
|
|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 2
Day 11 AM, n=5
|
504.0 Liters per minute
Standard Error 36.1
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 2
Day 11 PM, n=6
|
485.0 Liters per minute
Standard Error 42.6
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 2
Day 12 AM, n=5
|
508.0 Liters per minute
Standard Error 41.4
|
—
|
—
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—
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—
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—
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—
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—
|
|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 2
Day 12 PM, n=6
|
493.3 Liters per minute
Standard Error 42.8
|
—
|
—
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—
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—
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—
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—
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—
|
|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 2
Day 13 AM, n=5
|
500.0 Liters per minute
Standard Error 40.1
|
—
|
—
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—
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—
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—
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—
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—
|
|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 2
Day 13 PM, n=6
|
495.0 Liters per minute
Standard Error 45.8
|
—
|
—
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—
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—
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—
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—
|
|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 2
Day 14 AM, n=5
|
438.0 Liters per minute
Standard Error 46.6
|
—
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—
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—
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—
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—
|
|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 2
Day 14 PM, n=6
|
495.8 Liters per minute
Standard Error 48.8
|
—
|
—
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—
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—
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—
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—
|
|
PEFR as a Measure of Safety and Tolerability for FP 200 mcg in Period 2
Day 10 AM, n=4
|
515.0 Liters per minute
Standard Error 44.0
|
—
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—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Day 15 PM, Day 16,17,18,19,20,21,22,23,24,25,26,27,28 AM and PM in period 1Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. One participant who was supposed to receive FP 1000 mg during day 22-28 and FP 2000 mg during day 28-35 but this participant continued the 3rd escalation phase dose (FP 500 mg) in fourth escalation phase and took FP 1000 mg (4th phase dose) in the fifth escalation phase (days 28-35).
Outcome measures
| Measure |
FF 25 mcg
n=14 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 23 AM, n=1
|
530.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 23 PM, n=1
|
550.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
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—
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—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 24 AM, n=1
|
530.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 24 PM, n=1
|
540.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 25 AM, n=1
|
510.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 25 PM, n=1
|
500.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 26 AM, n=1
|
520.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 26 PM, n=1
|
550.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
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—
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—
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—
|
—
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—
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—
|
—
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—
|
—
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—
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—
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—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 27 AM, n=1
|
530.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
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—
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—
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—
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—
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—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 27 PM, n=1
|
580.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 28 AM, n=1
|
530.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 28 PM, n=1
|
500.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
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—
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—
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—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 15 PM, n=14
|
527.5 Liters per minute
Standard Error 29.7
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
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—
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—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 16 AM, n=13
|
503.8 Liters per minute
Standard Error 31.9
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 16 PM, n=14
|
520.4 Liters per minute
Standard Error 29.5
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 17 AM, n=13
|
510.0 Liters per minute
Standard Error 30.3
|
—
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—
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—
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—
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—
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—
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—
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—
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|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 17 PM, n=14
|
508.6 Liters per minute
Standard Error 31.2
|
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—
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—
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—
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—
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—
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|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 18 AM, n=12
|
497.5 Liters per minute
Standard Error 34.7
|
—
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—
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—
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—
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—
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—
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—
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—
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|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 18 PM, n=13
|
505.8 Liters per minute
Standard Error 28.5
|
—
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—
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—
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—
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—
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—
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—
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|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 19 AM, n=12
|
505.8 Liters per minute
Standard Error 35.2
|
—
|
—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 19 PM, n=13
|
506.9 Liters per minute
Standard Error 29.5
|
—
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—
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—
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—
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—
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—
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|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 20 AM, n=11
|
518.2 Liters per minute
Standard Error 35.9
|
—
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—
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—
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—
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—
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—
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—
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—
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|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 20 PM, n=13
|
517.3 Liters per minute
Standard Error 30.4
|
—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 21 AM, n=13
|
501.9 Liters per minute
Standard Error 32.1
|
—
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—
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—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 21 PM, n=11
|
493.6 Liters per minute
Standard Error 30.0
|
—
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—
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—
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—
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—
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—
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|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 22 AM, n=1
|
520.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 1
Day 22 PM, n=1
|
540.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
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—
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—
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|
SECONDARY outcome
Timeframe: Day 15 PM, Day 16,17,18,19,20,21 AM and PM in period 2Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=6 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 2
Day 15 PM, n=6
|
486.7 Liters per minute
Standard Error 43.8
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 2
Day 16 AM, n=6
|
476.7 Liters per minute
Standard Error 43.8
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 2
Day 16 PM, n=6
|
503.3 Liters per minute
Standard Error 46.8
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 2
Day 17 AM, n=6
|
493.3 Liters per minute
Standard Error 44.0
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 2
Day 17 PM, n=6
|
500.0 Liters per minute
Standard Error 45.9
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 2
Day 18 AM, n=6
|
476.7 Liters per minute
Standard Error 39.9
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 2
Day 18 PM, n=6
|
495.0 Liters per minute
Standard Error 42.8
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 2
Day 19 AM, n=5
|
454.0 Liters per minute
Standard Error 44.3
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 2
Day 19 PM, n=6
|
500.0 Liters per minute
Standard Error 45.1
|
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 2
Day 20 AM, n=5
|
524.0 Liters per minute
Standard Error 43.6
|
—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 2
Day 20 PM, n=6
|
501.7 Liters per minute
Standard Error 50.6
|
—
|
—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 2
Day 21 AM, n=6
|
490.0 Liters per minute
Standard Error 44.2
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 500 mcg in Period 2
Day 21 PM, n=6
|
496.7 Liters per minute
Standard Error 48.4
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Day 22 PM, Day 23,24,25,26,27,28,29,30,31,32,33,34,35 AM and PM in period 1Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise. One participant who was supposed to receive FP 1000 mg during day 22-28 and FP 2000 mg during day 28-35 but this participant continued the 3rd escalation phase dose (FP 500 mg) in fourth escalation phase and took FP 1000 mg (4th phase dose) in the fifth escalation phase (days 28-35).
Outcome measures
| Measure |
FF 25 mcg
n=11 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
Day 27 AM, n=11
|
493.6 Liters per minute
Standard Error 33.0
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
Day 27 PM, n=11
|
523.6 Liters per minute
Standard Error 37.7
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
Day 28 AM, n=11
|
500.0 Liters per minute
Standard Error 40.6
|
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
Day 28,PM, n=11
|
516.4 Liters per minute
Standard Error 33.9
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
Day 22 PM, n=6
|
523.2 Liters per minute
Standard Error 30.5
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
Day 23 AM, n=11
|
511.8 Liters per minute
Standard Error 36.4
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
Day 23 PM, n=11
|
516.4 Liters per minute
Standard Error 38.4
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
Day 24 AM, n=11
|
521.8 Liters per minute
Standard Error 38.0
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
Day 24 PM, n=11
|
520.9 Liters per minute
Standard Error 37.1
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
Day 25 AM, n=11
|
489.5 Liters per minute
Standard Error 35.1
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
Day 25 PM, n=10
|
521.0 Liters per minute
Standard Error 42.7
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
Day 26 AM, n=11
|
502.7 Liters per minute
Standard Error 37.0
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
Day 26 PM, n=11
|
517.3 Liters per minute
Standard Error 35.7
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
Day 29 PM, n=1
|
530.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
|
—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
Day 30 AM, n=1
|
520.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed..
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
Day 30 PM, n=1
|
530.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
Day 31 AM, n=1
|
510.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
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—
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—
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—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
Day 31 PM, n=1
|
530.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
Day 32 AM, n=1
|
520.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
Day 32 PM, n=1
|
550.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
Day 33 AM, n=1
|
530.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
Day 33 PM, n=1
|
540.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
Day 34 AM, n=1
|
510.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
Day 34 PM, n=1
|
520.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
Day 35 AM, n=1
|
540.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 1
Day 35 PM, n=1
|
550.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Day 22 PM, Day 23,24,25,26,27,28 AM and PM in period 2Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=6 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 2
Day 22 PM, n=6
|
493.3 Liters per minute
Standard Error 42.8
|
—
|
—
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—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 2
Day 23 AM, n=6
|
480.0 Liters per minute
Standard Error 43.4
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 2
Day 23 PM, n=6
|
506.7 Liters per minute
Standard Error 43.5
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 2
Day 24 AM, n=6
|
481.7 Liters per minute
Standard Error 39.4
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 2
Day 24 PM, n=6
|
505.0 Liters per minute
Standard Error 45.3
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 2
Day 25 AM, n=6
|
491.7 Liters per minute
Standard Error 43.9
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 2
Day 25 PM, n=6
|
510.0 Liters per minute
Standard Error 51.7
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 2
Day 26 AM, n=6
|
485.0 Liters per minute
Standard Error 45.3
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 2
Day 26 PM, n=6
|
501.7 Liters per minute
Standard Error 49.9
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 2
Day 27 AM, n=6
|
475.0 Liters per minute
Standard Error 42.3
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 2
Day 27 PM, n=6
|
490.0 Liters per minute
Standard Error 43.2
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
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—
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—
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—
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—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 2
Day 28 AM, n=5
|
452.0 Liters per minute
Standard Error 47.7
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
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—
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—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 1000 mcg in Period 2
Day 28,PM, n=5
|
476.0 Liters per minute
Standard Error 56.8
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29 PM, Day 30,31,32,33,34,35 AM and PM in period 1Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=10 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 1
Day 29 PM, n=10
|
520.5 Liters per minute
Standard Error 36.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 1
Day 30 AM, n=10
|
505.0 Liters per minute
Standard Error 39.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 1
Day 30 PM, n=10
|
520.0 Liters per minute
Standard Error 40.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 1
Day 31 AM, n=10
|
507.0 Liters per minute
Standard Error 37.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 1
Day 31 PM, n=10
|
521.0 Liters per minute
Standard Error 41.7
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 1
Day 32 AM, n=10
|
500.0 Liters per minute
Standard Error 39.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 1
Day 32 PM, n=10
|
524.0 Liters per minute
Standard Error 41.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 1
Day 33 AM, n=10
|
511.0 Liters per minute
Standard Error 40.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 1
Day 33 PM, n=10
|
511.5 Liters per minute
Standard Error 43.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 1
Day 34 AM, n=10
|
519.0 Liters per minute
Standard Error 38.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 1
Day 34 PM, n=10
|
517.0 Liters per minute
Standard Error 38.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 1
Day 35 AM, n=9
|
514.4 Liters per minute
Standard Error 40.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 1
Day 35 PM, n=9
|
543.9 Liters per minute
Standard Error 44.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29 PM, Day 30,31,32,33,34,35 AM and PM in period 2Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed.
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=6 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 2
Day 29 PM
|
506.7 Liters per minute
Standard Error 45.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 2
Day 30 AM
|
493.3 Liters per minute
Standard Error 45.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 2
Day 30 PM
|
496.7 Liters per minute
Standard Error 46.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 2
Day 31 AM
|
486.7 Liters per minute
Standard Error 48.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 2
Day 31 PM
|
485.0 Liters per minute
Standard Error 41.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 2
Day 32 AM
|
488.3 Liters per minute
Standard Error 44.7
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 2
Day 32 PM
|
513.3 Liters per minute
Standard Error 52.6
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
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—
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—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 2
Day 33 AM
|
495.0 Liters per minute
Standard Error 45.3
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 2
Day 33 PM
|
498.3 Liters per minute
Standard Error 44.1
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 2
Day 34 AM
|
481.7 Liters per minute
Standard Error 46.0
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
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—
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—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 2
Day 34 PM
|
498.3 Liters per minute
Standard Error 47.7
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
|
—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 2
Day 35 AM
|
483.3 Liters per minute
Standard Error 44.2
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for FP 2000 mcg in Period 2
Day 35 PM
|
493.3 Liters per minute
Standard Error 46.3
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Day 2 to 6 AM and PM, Day 7 PM in period 1Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=12 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 1
Day 2 AM, n=1
|
600.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
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—
|
—
|
—
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—
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—
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—
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—
|
—
|
—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 1
Day 2 PM, n=12
|
512.9 Liters per minute
Standard Error 33.4
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 1
Day 3 AM, n=1
|
600.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
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—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 1
Day 3 PM, n=12
|
517.1 Liters per minute
Standard Error 31.2
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 1
Day 4 AM, n=1
|
625.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 1
Day 4 PM, n=12
|
524.2 Liters per minute
Standard Error 32.9
|
—
|
—
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—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 1
Day 5 AM, n=1
|
600.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
|
—
|
—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 1
Day 5 PM, n=12
|
520.8 Liters per minute
Standard Error 32.3
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 1
Day 6 AM, n=1
|
600.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
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—
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—
|
—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 1
Day 6 PM, n=12
|
523.3 Liters per minute
Standard Error 33.5
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 1
Day 7 PM, n=12
|
527.5 Liters per minute
Standard Error 33.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 2,3,4,5,6,7 PM in period 2Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=4 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 2
Day 2 PM, n=4
|
557.5 Liters per minute
Standard Error 28.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 2
Day 3 PM, n=4
|
547.5 Liters per minute
Standard Error 60.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 2
Day 4 PM, n=4
|
545.0 Liters per minute
Standard Error 27.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 2
Day 5 PM, n=4
|
552.5 Liters per minute
Standard Error 46.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 2
Day 6 PM, n=4
|
577.5 Liters per minute
Standard Error 26.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 100 mcg in Period 2
Day 7 PM, n=3
|
603.3 Liters per minute
Standard Error 32.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8 PM, Day 9 to 14 AM and PM in period 1Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=12 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 1
Day 8 PM, n=12
|
521.7 Liters per minute
Standard Error 31.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 1
Day 9 AM, n=10
|
473.0 Liters per minute
Standard Error 30.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 1
Day 9 PM, n=12
|
515.4 Liters per minute
Standard Error 34.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 1
Day 10 AM, n=10
|
470.0 Liters per minute
Standard Error 33.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 1
Day 10 PM, n=12
|
512.9 Liters per minute
Standard Error 32.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 1
Day 11 AM, n=10
|
466.7 Liters per minute
Standard Error 36.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 1
Day 11 PM, n=11
|
492.5 Liters per minute
Standard Error 35.2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 1
Day 12 AM, n=9
|
451.1 Liters per minute
Standard Error 28.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 1
Day 12 PM, n=11
|
509.5 Liters per minute
Standard Error 33.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 1
Day 13 AM, n=9
|
457.8 Liters per minute
Standard Error 33.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 1
Day 13 PM, n=11
|
506.8 Liters per minute
Standard Error 33.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 1
Day 14 AM, n=11
|
480.5 Liters per minute
Standard Error 30.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 1
Day 14 PM, n=11
|
496.4 Liters per minute
Standard Error 32.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 8 PM, Day 9 to 14 AM and PM in period 2Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed.
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=5 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 2
Day 8 PM
|
560.0 Liters per minute
Standard Error 43.3
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 2
Day 9 AM
|
552.0 Liters per minute
Standard Error 40.1
|
—
|
—
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—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 2
Day 9 PM
|
560.0 Liters per minute
Standard Error 34.7
|
—
|
—
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—
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—
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—
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—
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—
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|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 2
Day 10 AM
|
552.0 Liters per minute
Standard Error 34.9
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 2
Day 10 PM
|
556.0 Liters per minute
Standard Error 30.7
|
—
|
—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 2
Day 11 AM
|
562.0 Liters per minute
Standard Error 26.7
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 2
Day 11 PM
|
574.0 Liters per minute
Standard Error 30.4
|
—
|
—
|
—
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—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 2
Day 12 AM
|
568.0 Liters per minute
Standard Error 29.3
|
—
|
—
|
—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 2
Day 12 PM
|
578.0 Liters per minute
Standard Error 44.2
|
—
|
—
|
—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 2
Day 13 AM
|
562.0 Liters per minute
Standard Error 28.1
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 2
Day 13 PM
|
588.0 Liters per minute
Standard Error 37.6
|
—
|
—
|
—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 2
Day 14 AM
|
586.0 Liters per minute
Standard Error 22.2
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 400 mcg in Period 2
Day 14 PM
|
590.0 Liters per minute
Standard Error 44.6
|
—
|
—
|
—
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—
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—
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—
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—
|
—
|
SECONDARY outcome
Timeframe: Day 15,16, 17, 18, 19, 20, 21 AM and PM in period 1Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=11 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 1
Day 15 AM, n=1
|
610.0 Liters per minute
Standard Error NA
NA indicates standard error could not be calculated as only one participant was analyzed.
|
—
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—
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—
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—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 1
Day 15 PM, n=11
|
515.5 Liters per minute
Standard Error 30.1
|
—
|
—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 1
Day 16 AM, n=11
|
494.5 Liters per minute
Standard Error 31.9
|
—
|
—
|
—
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—
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—
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—
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—
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—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 1
Day 16 PM, n=11
|
507.3 Liters per minute
Standard Error 34.9
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 1
Day 17 AM, n=11
|
484.1 Liters per minute
Standard Error 33.4
|
—
|
—
|
—
|
—
|
—
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—
|
—
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—
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—
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—
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—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 1
Day 17 PM, n=11
|
505.0 Liters per minute
Standard Error 34.8
|
—
|
—
|
—
|
—
|
—
|
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—
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—
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—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 1
Day 18 AM, n=11
|
492.7 Liters per minute
Standard Error 33.4
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 1
Day 18 PM, n=11
|
503.2 Liters per minute
Standard Error 36.4
|
—
|
—
|
—
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—
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—
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—
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—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 1
Day 19 AM, n=11
|
483.2 Liters per minute
Standard Error 29.7
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 1
Day 19 PM, n=11
|
487.7 Liters per minute
Standard Error 38.0
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 1
Day 20 AM, n=11
|
483.6 Liters per minute
Standard Error 31.7
|
—
|
—
|
—
|
—
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—
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|
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—
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—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 1
Day 20 PM, n=11
|
517.7 Liters per minute
Standard Error 33.9
|
—
|
—
|
—
|
—
|
—
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—
|
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—
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—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 1
Day 21 AM, n=11
|
490.5 Liters per minute
Standard Error 27.2
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
|
—
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—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 1
Day 21 PM, n=11
|
509.1 Liters per minute
Standard Error 32.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 15 PM, Day 16, 17, 18, 19, 20, 21 AM and PM in period 2Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed.
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=5 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 2
Day 15 PM
|
578.0 Liters per minute
Standard Error 32.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 2
Day 16 AM
|
568.0 Liters per minute
Standard Error 37.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 2
Day 16 PM
|
572.0 Liters per minute
Standard Error 45.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 2
Day 17 AM
|
572.0 Liters per minute
Standard Error 27.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 2
Day 17 PM
|
558.0 Liters per minute
Standard Error 46.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 2
Day 18 AM
|
558.0 Liters per minute
Standard Error 45.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 2
Day 18 PM
|
568.0 Liters per minute
Standard Error 53.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 2
Day 19 AM
|
572.0 Liters per minute
Standard Error 46.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 2
Day 19 PM
|
584.0 Liters per minute
Standard Error 47.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 2
Day 20 AM
|
590.0 Liters per minute
Standard Error 37.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 2
Day 20 PM
|
590.0 Liters per minute
Standard Error 37.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 2
Day 21 AM
|
574.0 Liters per minute
Standard Error 23.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 800 mcg in Period 2
Day 21 PM
|
606.0 Liters per minute
Standard Error 38.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 22 PM, Day 23,24,25,26,27,28 AM and PM in period 1Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed.
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=11 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 1
Day 22 PM
|
506.4 Liters per minute
Standard Error 33.9
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 1
Day 23 AM
|
496.4 Liters per minute
Standard Error 29.8
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 1
Day 23 PM
|
512.7 Liters per minute
Standard Error 32.3
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 1
Day 24 AM
|
498.2 Liters per minute
Standard Error 34.8
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 1
Day 24 PM
|
510.5 Liters per minute
Standard Error 34.9
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 1
Day 25 AM
|
500.5 Liters per minute
Standard Error 32.8
|
—
|
—
|
—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 1
Day 25 PM
|
514.1 Liters per minute
Standard Error 33.2
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 1
Day 26 AM
|
499.1 Liters per minute
Standard Error 31.3
|
—
|
—
|
—
|
—
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—
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—
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—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 1
Day 26 PM
|
512.3 Liters per minute
Standard Error 35.2
|
—
|
—
|
—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 1
Day 27 AM
|
491.4 Liters per minute
Standard Error 31.0
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 1
Day 27 PM
|
497.7 Liters per minute
Standard Error 37.3
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 1
Day 28 AM
|
476.8 Liters per minute
Standard Error 27.9
|
—
|
—
|
—
|
—
|
—
|
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—
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—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 1
Day 28 PM
|
526.8 Liters per minute
Standard Error 33.9
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 22 PM, Day 23,24,25,26,27,28 AM and PM in period 2Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed.
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=5 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 2
Day 22 PM
|
594.0 Liters per minute
Standard Error 47.8
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 2
Day 23 AM
|
578.0 Liters per minute
Standard Error 40.0
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
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—
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—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 2
Day 23 PM
|
586.0 Liters per minute
Standard Error 46.4
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 2
Day 24 AM
|
556.0 Liters per minute
Standard Error 37.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 2
Day 24 PM
|
556.0 Liters per minute
Standard Error 45.2
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 2
Day 25 AM
|
564.0 Liters per minute
Standard Error 50.6
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 2
Day 25 PM
|
594.0 Liters per minute
Standard Error 45.4
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 2
Day 26 AM
|
584.0 Liters per minute
Standard Error 45.6
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 2
Day 26 PM
|
568.0 Liters per minute
Standard Error 51.1
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 2
Day 27 AM
|
568.0 Liters per minute
Standard Error 52.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 2
Day 27 PM
|
584.0 Liters per minute
Standard Error 35.3
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 2
Day 28 AM
|
574.0 Liters per minute
Standard Error 30.1
|
—
|
—
|
—
|
—
|
—
|
—
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—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 1600 mcg in Period 2
Day 28 PM
|
630.0 Liters per minute
Standard Error 46.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29 PM, Day 30, 31,32,33,34,35 AM and PM in period 1Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=10 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 1
Day 29 PM, n=10
|
493.0 Liters per minute
Standard Error 31.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 1
Day 30 AM, n=10
|
482.0 Liters per minute
Standard Error 33.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 1
Day 30 PM, n=10
|
502.0 Liters per minute
Standard Error 33.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 1
Day 31 AM, n=10
|
482.0 Liters per minute
Standard Error 34.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 1
Day 31 PM, n=10
|
496.0 Liters per minute
Standard Error 32.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 1
Day 32 AM, n=10
|
482.0 Liters per minute
Standard Error 30.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 1
Day 32 PM, n=10
|
488.0 Liters per minute
Standard Error 33.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 1
Day 33 AM, n=10
|
483.0 Liters per minute
Standard Error 29.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 1
Day 33 PM, n=10
|
490.0 Liters per minute
Standard Error 35.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 1
Day 34 AM, n=10
|
489.0 Liters per minute
Standard Error 31.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 1
Day 34 PM, n=9
|
522.2 Liters per minute
Standard Error 33.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 1
Day 35 AM, n=10
|
474.0 Liters per minute
Standard Error 33.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 1
Day 35 PM, n=10
|
488.0 Liters per minute
Standard Error 30.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 29 PM, Day 30, 31,32,33,34,35 AM and PM in period 2Population: All subjects Population. Only those participants with data available at the indicated time points were analyzed (represented by n=X in the category titles).
PEFR is a participant's maximum speed of expiration and was measured using a peak flow meter. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=5 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 2
Day 29 PM, n=5
|
596.0 Liters per minute
Standard Error 43.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 2
Day 30 AM, n=5
|
604.0 Liters per minute
Standard Error 22.7
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 2
Day 30 PM, n=5
|
586.0 Liters per minute
Standard Error 41.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 2
Day 31 AM, n=4
|
562.5 Liters per minute
Standard Error 33.5
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 2
Day 31 PM, n=4
|
547.5 Liters per minute
Standard Error 43.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 2
Day 32 AM, n=4
|
592.5 Liters per minute
Standard Error 38.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 2
Day 32 PM, n=4
|
587.5 Liters per minute
Standard Error 18.8
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 2
Day 33 AM, n=4
|
567.5 Liters per minute
Standard Error 30.3
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 2
Day 33 PM, n=4
|
565.0 Liters per minute
Standard Error 42.9
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 2
Day 34 AM, n=4
|
585.0 Liters per minute
Standard Error 38.4
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 2
Day 34 PM, n=4
|
583.8 Liters per minute
Standard Error 29.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 2
Day 35 AM, n=4
|
577.5 Liters per minute
Standard Error 35.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Peak Expiratory Flow Rate (PEFR) as a Measure of Safety and Tolerability for BUD 3200 mcg in Period 2
Day 35 PM, n=4
|
597.5 Liters per minute
Standard Error 38.6
|
—
|
—
|
—
|
—
|
—
|
—
|
—
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—
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—
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—
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—
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—
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—
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—
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—
|
SECONDARY outcome
Timeframe: Up to Week 18Population: All subjects Population.
SBP and DBP were measured after participants had rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 18Population: All subjects Population
Pulse rate was measured after participants had rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 18Population: All subjects Population.
Respiratory rate was measured after participants had rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 18Population: All subjects Population.
Temperature was measured after participants have been rested in supine position for at least 5 minutes. Results are presented treatment wise. No data collected separately for this outcome measure as any abnormal value would be recorded as an Adverse Event.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 18Population: All subjects Population.
Physical examinations included assessment of the cardiovascular, respiratory, gastrointestinal, skin, abdomen (liver and spleen), and neurological systems. This analysis was planned and data was not collected and captured in the database. Results are presented treatment wise.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to Week 18Population: All subjects Population.
Blood samples were collected for assessement of following hematology parameters: basophils, eosinophils, Erythrocyte mean corpuscular volume (MCV), hemoglobin, hematocrit, Erythrocyte mean corpuscular hemoglobin (MCH), leukocytes, lymphocytes, monocytes, platelets. Results are presented treatment wise. Only participants with clinically significant abnormal hematology data was reported.
Outcome measures
| Measure |
FF 25 mcg
n=17 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
n=20 Participants
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
n=19 Participants
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
n=19 Participants
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
n=18 Participants
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
n=18 Participants
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
n=21 Participants
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
n=20 Participants
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
n=20 Participants
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
n=18 Participants
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
n=17 Participants
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
n=18 Participants
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
n=18 Participants
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
n=18 Participants
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
n=18 Participants
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
n=18 Participants
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Hematology Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 18Population: All subjects Population.
Blood samples were collecte for assessment of following chemistry parametres:Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), albumin, alkaline phosphatase, bilirubin, calcium, creatinine, glucose, direct bilirubin, potassium, protein, sodium, urea. Results are presented treatment wise. Only participants with clinically significant abnormal chemistry data was reported.
Outcome measures
| Measure |
FF 25 mcg
n=17 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
n=20 Participants
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
n=19 Participants
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
n=19 Participants
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
n=18 Participants
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
n=18 Participants
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
n=21 Participants
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
n=20 Participants
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
n=20 Participants
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
n=18 Participants
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
n=17 Participants
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
n=18 Participants
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
n=18 Participants
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
n=18 Participants
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
n=18 Participants
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
n=18 Participants
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Chemistry Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 18Population: All subjects Population.
Urine sample were collected to assess following urine parameters: potential of hydrogen (pH), glucose, protein, blood and ketones by dipstick. Results are presented treatment wise. Only participants with clinically significant abnormal urinalysis data was reported.
Outcome measures
| Measure |
FF 25 mcg
n=17 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
n=20 Participants
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
n=19 Participants
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
n=19 Participants
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
n=18 Participants
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
n=18 Participants
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
n=21 Participants
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
n=20 Participants
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
n=20 Participants
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
n=18 Participants
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
n=17 Participants
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
n=18 Participants
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
n=18 Participants
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
n=18 Participants
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
n=18 Participants
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
n=18 Participants
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormal Urinalysis Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose) in Period 1Population: All Subjects Population.
FEV1 was measured with participants in a sitting position using a calibrated spirometer in accordance with American Thoracic Society (ATS) guidelines using European Respiratory Society (ERS)guidelines for predicted values. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=12 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
n=14 Participants
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
n=15 Participants
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
n=12 Participants
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV 1) in Period 1
|
3.18 Liter
Standard Error 0.151
|
3.02 Liter
Standard Error 0.166
|
3.50 Liter
Standard Error 0.269
|
3.29 Liter
Standard Error 0.274
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose) in Period 2Population: All Subjects Population.
FEV1 was measured with participants in a sitting position using a calibrated spirometer in accordance with ATS guidelines using ERS guidelines for predicted values. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=5 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
n=6 Participants
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
n=6 Participants
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
n=6 Participants
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV 1) in Period 2
|
2.67 Liter
Standard Error 0.482
|
3.44 Liter
Standard Error 0.431
|
2.68 Liter
Standard Error 0.278
|
3.46 Liter
Standard Error 0.257
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose) in Period 1Population: All Subjects Population.
FVC was measured with participants in a sitting position using a calibrated spirometer in accordance with ATS guidelines using ERS guidelines for predicted values. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=12 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
n=14 Participants
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
n=15 Participants
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
n=12 Participants
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Forced Vital Capacity (FVC) in Period 1
|
4.55 Liter
Standard Error 0.221
|
4.36 Liter
Standard Error 0.222
|
5.15 Liter
Standard Error 0.287
|
4.70 Liter
Standard Error 0.406
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 (pre-dose) in Period 2Population: All Subjects Population.
FVC was measured with participants in a sitting position using a calibrated spirometer in accordance with ATS guidelines using ERS guidelines for predicted values. Results are presented treatment wise.
Outcome measures
| Measure |
FF 25 mcg
n=5 Participants
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
n=6 Participants
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
n=6 Participants
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
n=6 Participants
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
BUD 3200 mcg
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Forced Vital Capacity (FVC) in Period 2
|
4.11 Liter
Standard Error 0.570
|
4.85 Liter
Standard Error 0.602
|
4.09 Liter
Standard Error 0.386
|
4.90 Liter
Standard Error 0.410
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
FF 25 mcg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
FF 100 mcg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
FF 200 mcg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
FF 400 mcg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
FF 800 mcg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
FP 50 mcg
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
FP 200 mcg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
FP 500 mcg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
FP 1000 mcg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
FP 2000 mcg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BUD 100 mcg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BUD 400 mcg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
BUD 800 mcg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
BUD 1600 mcg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
BUD 3200 mcg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=17 participants at risk
Participants received matching placebo ELLIPTA or DISKUS as total daily dose for 7 days.
|
FF 25 mcg
n=20 participants at risk
Participants received placebo FF ELLIPTA 25 mcg 1 puff as total daily dose for 7 days.
|
FF 100 mcg
n=19 participants at risk
Participants received FF ELLIPTA 100 mcg 1 puff PM as total daily dose for 7 days.
|
FF 200 mcg
n=19 participants at risk
Participants received FF ELLIPTA 200 mcg 1 puff PM as total daily dose for 7 days.
|
FF 400 mcg
n=18 participants at risk
Participants received FF ELLIPTA 200 mcg 2 puffs PM as total daily dose for 7 days.
|
FF 800 mcg
n=18 participants at risk
Participants received FF ELLIPTA 200 mcg 4 puffs PM as total daily dose for 7 days.
|
FP 50 mcg
n=21 participants at risk
Participants received FF DISKUS 50 mcg 1 puff PM as total daily dose for 7 days.
|
FP 200 mcg
n=20 participants at risk
Participants received FF DISKUS 100 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 500 mcg
n=20 participants at risk
Participants received FF DISKUS 250mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 1000 mcg
n=18 participants at risk
Participants received FF DISKUS 500 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
FP 2000 mcg
n=17 participants at risk
Participants received FF DISKUS 500 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 100 mcg
n=18 participants at risk
Participants received BUD Turbuhaler 100 mcg 1 puff PM as total daily dose for 7 days.
|
BUD 400 mcg
n=18 participants at risk
Participants received BUD Turbuhaler 200 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 800 mcg
n=18 participants at risk
Participants received BUD Turbuhaler 400 mcg 1 puff AM and 1 puff PM as total daily dose for 7 days.
|
BUD 1600 mcg
n=18 participants at risk
Participants received BUD Turbuhaler 400 mcg 2 puff AM and 2 puff PM as total daily dose for 7 days.
|
BUD 3200 mcg
n=18 participants at risk
Participants received BUD Turbuhaler 400 mcg 4 puffs AM and PM as total daily dose for 7 days.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Headache
|
23.5%
4/17 • Number of events 8 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
25.0%
5/20 • Number of events 5 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
15.8%
3/19 • Number of events 3 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.3%
1/19 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
11.1%
2/18 • Number of events 2 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
9.5%
2/21 • Number of events 2 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
11.8%
2/17 • Number of events 2 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
11.1%
2/18 • Number of events 2 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
11.1%
2/18 • Number of events 2 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
16.7%
3/18 • Number of events 3 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
16.7%
3/18 • Number of events 3 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
11.1%
2/18 • Number of events 3 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Immune system disorders
Seasonal allergy
|
5.9%
1/17 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.0%
1/20 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.3%
1/19 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
14.3%
3/21 • Number of events 3 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.0%
1/20 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.0%
1/20 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.3%
1/19 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
11.1%
2/18 • Number of events 3 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
4.8%
1/21 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.0%
1/20 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
11.1%
2/18 • Number of events 2 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.9%
1/17 • Number of events 3 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
9.5%
2/21 • Number of events 3 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.0%
1/20 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.9%
1/17 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 2 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
4.8%
1/21 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
11.1%
2/18 • Number of events 2 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
11.1%
2/18 • Number of events 2 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
General disorders
Catheter site bruise
|
11.8%
2/17 • Number of events 2 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.3%
1/19 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
4.8%
1/21 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.9%
1/17 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.9%
1/17 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
General disorders
Chest discomfort
|
11.8%
2/17 • Number of events 4 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
10.5%
2/19 • Number of events 2 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
9.5%
2/21 • Number of events 2 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
11.1%
2/18 • Number of events 2 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
11.1%
2/18 • Number of events 2 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
4.8%
1/21 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.9%
1/17 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.3%
1/19 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
4.8%
1/21 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.3%
1/19 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
11.8%
2/17 • Number of events 2 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.0%
1/20 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
11.8%
2/17 • Number of events 2 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.3%
1/19 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
General disorders
Catheter site pain
|
5.9%
1/17 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
11.1%
2/18 • Number of events 2 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.9%
1/17 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.9%
1/17 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.3%
1/19 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
4.8%
1/21 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
4.8%
1/21 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
5.9%
1/17 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.0%
1/20 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
General disorders
Catheter site related reaction
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.9%
1/17 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
4.8%
1/21 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.0%
1/20 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.9%
1/17 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.9%
1/17 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.3%
1/19 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.0%
1/20 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
General disorders
Catheter site swelling
|
5.9%
1/17 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
5.9%
1/17 • Number of events 2 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
4.8%
1/21 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.3%
1/19 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Eye disorders
Eye swelling
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.3%
1/19 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
General disorders
Fatigue
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
General disorders
Feeling jittery
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
4.8%
1/21 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 2 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Reproductive system and breast disorders
Genital discomfort
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.3%
1/19 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Metabolism and nutrition disorders
Gout
|
5.9%
1/17 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Skin and subcutaneous tissue disorders
Keloid scar
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
4.8%
1/21 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.9%
1/17 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.0%
1/20 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
General disorders
Peripheral swelling
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.0%
1/20 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Gastrointestinal disorders
Saliva altered
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Injury, poisoning and procedural complications
Scratch
|
5.9%
1/17 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sinonasal obstruction
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.3%
1/19 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
4.8%
1/21 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.3%
1/19 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Nervous system disorders
Syncope
|
5.9%
1/17 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.6%
1/18 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Surgical and medical procedures
Tooth repair
|
5.9%
1/17 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
5.9%
1/17 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
General disorders
Vessel puncture site bruise
|
5.9%
1/17 • Number of events 2 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/21 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/19 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
4.8%
1/21 • Number of events 1 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/20 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/17 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
0.00%
0/18 • Serious adverse events and non-serious adverse events were collected up to 18 weeks.
All subjects Population was used to collect the adverse events.
|
Additional Information
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