Trial Outcomes & Findings for Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations (NCT NCT01847443)
NCT ID: NCT01847443
Last Updated: 2014-04-11
Results Overview
AUC(0-t) for 2 mg test was compared with 2 mg reference gum
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
84 participants
Primary outcome timeframe
Blood samples to be collected from baseline to 12 hours post dose
Results posted on
2014-04-11
Participant Flow
Potential participants were recruited at a single site in the UK.
A total of 160 participants were screened for this study, of which 84 participants were randomized. Seventy seven participants completed the study.
Participant milestones
| Measure |
2mg Mint Gum/4mg Ref Gum/4mg Mint Gum/2mg Ref Gum
Participants randomly received 2mg nicotine mint gum or 4mg reference (ref) nicotine gum or 4mg nicotine mint gum or 2mg ref nicotine gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
|
4mg Ref Gum/2mg Ref Gum/2mg Mint Gum/4mg Mint Gum
Participants randomly received 4mg ref nicotine gum or 2mg ref nicotine gum or 2mg nicotine mint gum or 4mg nicotine mint gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
|
2mg Ref Gum/4mg Mint Gum/4mg Ref Gum/2mg Mint Gum
Participants randomly received 2mg ref nicotine gum or 4mg nicotine mint gum or 4mg ref nicotine gum or 2mg nicotine mint gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
|
4mg Mint Gum/2mg Mint Gum/2mg Ref Gum/4mg Ref Gum
Participants randomly received 4mg nicotine mint gum or 2mg nicotine mint gum or 2mg ref nicotine gum or 4mg ref nicotine gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
|
|---|---|---|---|---|
|
Study Period 1
STARTED
|
21
|
21
|
21
|
21
|
|
Study Period 1
COMPLETED
|
21
|
20
|
21
|
21
|
|
Study Period 1
NOT COMPLETED
|
0
|
1
|
0
|
0
|
|
Washout Period Before Study Period 2
STARTED
|
21
|
20
|
21
|
21
|
|
Washout Period Before Study Period 2
COMPLETED
|
19
|
19
|
21
|
21
|
|
Washout Period Before Study Period 2
NOT COMPLETED
|
2
|
1
|
0
|
0
|
|
Study Period 2
STARTED
|
19
|
19
|
21
|
21
|
|
Study Period 2
COMPLETED
|
19
|
19
|
21
|
21
|
|
Study Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period Before Study Period 3
STARTED
|
19
|
19
|
21
|
21
|
|
Washout Period Before Study Period 3
COMPLETED
|
18
|
19
|
21
|
21
|
|
Washout Period Before Study Period 3
NOT COMPLETED
|
1
|
0
|
0
|
0
|
|
Study Period 3
STARTED
|
18
|
19
|
21
|
21
|
|
Study Period 3
COMPLETED
|
18
|
19
|
21
|
21
|
|
Study Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period Before Study Period 4
STARTED
|
18
|
19
|
21
|
21
|
|
Washout Period Before Study Period 4
COMPLETED
|
16
|
19
|
21
|
21
|
|
Washout Period Before Study Period 4
NOT COMPLETED
|
2
|
0
|
0
|
0
|
|
Study Period 4
STARTED
|
16
|
19
|
21
|
21
|
|
Study Period 4
COMPLETED
|
16
|
19
|
21
|
21
|
|
Study Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
2mg Mint Gum/4mg Ref Gum/4mg Mint Gum/2mg Ref Gum
Participants randomly received 2mg nicotine mint gum or 4mg reference (ref) nicotine gum or 4mg nicotine mint gum or 2mg ref nicotine gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
|
4mg Ref Gum/2mg Ref Gum/2mg Mint Gum/4mg Mint Gum
Participants randomly received 4mg ref nicotine gum or 2mg ref nicotine gum or 2mg nicotine mint gum or 4mg nicotine mint gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
|
2mg Ref Gum/4mg Mint Gum/4mg Ref Gum/2mg Mint Gum
Participants randomly received 2mg ref nicotine gum or 4mg nicotine mint gum or 4mg ref nicotine gum or 2mg nicotine mint gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
|
4mg Mint Gum/2mg Mint Gum/2mg Ref Gum/4mg Ref Gum
Participants randomly received 4mg nicotine mint gum or 2mg nicotine mint gum or 2mg ref nicotine gum or 4mg ref nicotine gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
|
|---|---|---|---|---|
|
Study Period 1
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Washout Period Before Study Period 2
Adverse Event
|
1
|
1
|
0
|
0
|
|
Washout Period Before Study Period 2
Other reason
|
1
|
0
|
0
|
0
|
|
Washout Period Before Study Period 3
Other reason
|
1
|
0
|
0
|
0
|
|
Washout Period Before Study Period 4
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Washout Period Before Study Period 4
Positive alcohol test
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Comparison of Pharmacokinetic Profiles of Two Nicotine Gum Formulations
Baseline characteristics by cohort
| Measure |
Total Participants
n=84 Participants
|
|---|---|
|
Age, Continuous
|
26.8 Years
STANDARD_DEVIATION 6.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
44 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Blood samples to be collected from baseline to 12 hours post dosePopulation: Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration \>5% of Cmax.
AUC(0-t) for 2 mg test was compared with 2 mg reference gum
Outcome measures
| Measure |
Test Nicotine Gum (2 mg)
n=62 Participants
A single dose of Nicotine Mint Gum (2 mg) to be chewed.
|
Reference Nicotine Gum (2 mg)
n=62 Participants
A single dose of Reference Nicotine Gum (2 mg) to be chewed.
|
Test Nicotine Gum (4 mg)
A single dose of Nicotine Mint Gum (4 mg) to be chewed.
|
Reference Nicotine Gum (4 mg)
A single dose of Reference Nicotine Gum (4 mg) to be chewed.
|
|---|---|---|---|---|
|
Area Under the Curve From Time 0 to Time 't' [AUC(0-t)] of Nicotine 2 mg Test and Reference Product
|
11.49 hr*ng/mL
Standard Deviation 4.224
|
10.24 hr*ng/mL
Standard Deviation 3.768
|
—
|
—
|
PRIMARY outcome
Timeframe: Blood samples to be collected from baseline to 12 hours post dosePopulation: Bioequivalence evaluable subjects' population: participants randomized to 1of 4 treatment sequences; took atleast one dose of study medication (both test and ref) in 2 mg dose and/or in 4 mg doses; did not have any AE assimilated to vomiting in first 4h post-treatment; and did not have baseline nicotine concentration \>5% of Cmax.
AUC(0-t) of Nicotine 4 mg test was compared with 4 mg reference gum
Outcome measures
| Measure |
Test Nicotine Gum (2 mg)
n=73 Participants
A single dose of Nicotine Mint Gum (2 mg) to be chewed.
|
Reference Nicotine Gum (2 mg)
n=73 Participants
A single dose of Reference Nicotine Gum (2 mg) to be chewed.
|
Test Nicotine Gum (4 mg)
A single dose of Nicotine Mint Gum (4 mg) to be chewed.
|
Reference Nicotine Gum (4 mg)
A single dose of Reference Nicotine Gum (4 mg) to be chewed.
|
|---|---|---|---|---|
|
AUC(0-t) of Nicotine 4 mg Test and Reference Product
|
23.44 hr*ng/mL
Standard Deviation 7.593
|
21.50 hr*ng/mL
Standard Deviation 6.874
|
—
|
—
|
PRIMARY outcome
Timeframe: Blood samples to be collected from baseline to 12 hours post dosePopulation: Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration \>5% of Cmax.
Cmax for 2 mg test was compared with 2 mg reference gum
Outcome measures
| Measure |
Test Nicotine Gum (2 mg)
n=62 Participants
A single dose of Nicotine Mint Gum (2 mg) to be chewed.
|
Reference Nicotine Gum (2 mg)
n=62 Participants
A single dose of Reference Nicotine Gum (2 mg) to be chewed.
|
Test Nicotine Gum (4 mg)
A single dose of Nicotine Mint Gum (4 mg) to be chewed.
|
Reference Nicotine Gum (4 mg)
A single dose of Reference Nicotine Gum (4 mg) to be chewed.
|
|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Nicotine 2 mg Test and Reference Product
|
3.93 ng/mL
Standard Deviation 1.232
|
3.72 ng/mL
Standard Deviation 1.289
|
—
|
—
|
PRIMARY outcome
Timeframe: Blood samples to be collected from baseline to 12 hours post-dosePopulation: Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration \>5% of Cmax.
Cmax for 4 mg test was compared with 4 mg reference gum
Outcome measures
| Measure |
Test Nicotine Gum (2 mg)
n=73 Participants
A single dose of Nicotine Mint Gum (2 mg) to be chewed.
|
Reference Nicotine Gum (2 mg)
n=73 Participants
A single dose of Reference Nicotine Gum (2 mg) to be chewed.
|
Test Nicotine Gum (4 mg)
A single dose of Nicotine Mint Gum (4 mg) to be chewed.
|
Reference Nicotine Gum (4 mg)
A single dose of Reference Nicotine Gum (4 mg) to be chewed.
|
|---|---|---|---|---|
|
Cmax of Nicotine 4 mg Test and Reference Product
|
7.49 ng/mL
Standard Deviation 1.720
|
6.98 ng/mL
Standard Deviation 1.777
|
—
|
—
|
SECONDARY outcome
Timeframe: Blood samples to be collected from baseline to 12 hours post dosePopulation: Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration \>5% of Cmax.
Tmax for 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum
Outcome measures
| Measure |
Test Nicotine Gum (2 mg)
n=62 Participants
A single dose of Nicotine Mint Gum (2 mg) to be chewed.
|
Reference Nicotine Gum (2 mg)
n=62 Participants
A single dose of Reference Nicotine Gum (2 mg) to be chewed.
|
Test Nicotine Gum (4 mg)
n=73 Participants
A single dose of Nicotine Mint Gum (4 mg) to be chewed.
|
Reference Nicotine Gum (4 mg)
n=73 Participants
A single dose of Reference Nicotine Gum (4 mg) to be chewed.
|
|---|---|---|---|---|
|
Time to Maximum Observed Concentration (Tmax) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
|
0.75 hr
Interval 0.5 to 1.0
|
0.75 hr
Interval 0.5 to 1.5
|
0.75 hr
Interval 0.5 to 1.5
|
0.75 hr
Interval 0.2 to 2.0
|
SECONDARY outcome
Timeframe: Blood samples to be collected from baseline to 12 hours post dosePopulation: Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration \>5% of Cmax.
T1/2 of 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum
Outcome measures
| Measure |
Test Nicotine Gum (2 mg)
n=62 Participants
A single dose of Nicotine Mint Gum (2 mg) to be chewed.
|
Reference Nicotine Gum (2 mg)
n=62 Participants
A single dose of Reference Nicotine Gum (2 mg) to be chewed.
|
Test Nicotine Gum (4 mg)
n=73 Participants
A single dose of Nicotine Mint Gum (4 mg) to be chewed.
|
Reference Nicotine Gum (4 mg)
n=73 Participants
A single dose of Reference Nicotine Gum (4 mg) to be chewed.
|
|---|---|---|---|---|
|
Apparent Terminal Elimination Half-life (T1/2) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
|
2.12 hr
Interval 1.4 to 3.4
|
2.03 hr
Interval 1.2 to 4.2
|
2.01 hr
Interval 1.3 to 4.1
|
2.02 hr
Interval 1.3 to 3.4
|
SECONDARY outcome
Timeframe: Blood samples to be collected from baseline to 12 hours post dosePopulation: Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration \>5% of Cmax.
Kel for 2 mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum
Outcome measures
| Measure |
Test Nicotine Gum (2 mg)
n=62 Participants
A single dose of Nicotine Mint Gum (2 mg) to be chewed.
|
Reference Nicotine Gum (2 mg)
n=62 Participants
A single dose of Reference Nicotine Gum (2 mg) to be chewed.
|
Test Nicotine Gum (4 mg)
n=73 Participants
A single dose of Nicotine Mint Gum (4 mg) to be chewed.
|
Reference Nicotine Gum (4 mg)
n=73 Participants
A single dose of Reference Nicotine Gum (4 mg) to be chewed.
|
|---|---|---|---|---|
|
Apparent Terminal Elimination Rate Constant (Kel) of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
|
0.33 1/hr
Interval 0.2 to 0.5
|
0.34 1/hr
Interval 0.2 to 0.6
|
0.34 1/hr
Interval 0.2 to 0.5
|
0.34 1/hr
Interval 0.2 to 0.5
|
SECONDARY outcome
Timeframe: Blood samples to be collected from baseline to 12 hours post dosePopulation: Bioequivalence evaluable subjects' population: participants randomized to 1 of 4 treatment sequences; took atleast one dose of study medication (both test and reference) in 2 mg dose and/or in 4 mg doses; did not have any adverse event assimilated to vomiting in first 4 h post-treatment; and did not have baseline nicotine concentration \>5% of Cmax.
AUC(0-∞) for 2mg test was compared with 2 mg reference gum, and 4 mg test was compared with 4 mg reference gum
Outcome measures
| Measure |
Test Nicotine Gum (2 mg)
n=62 Participants
A single dose of Nicotine Mint Gum (2 mg) to be chewed.
|
Reference Nicotine Gum (2 mg)
n=62 Participants
A single dose of Reference Nicotine Gum (2 mg) to be chewed.
|
Test Nicotine Gum (4 mg)
n=73 Participants
A single dose of Nicotine Mint Gum (4 mg) to be chewed.
|
Reference Nicotine Gum (4 mg)
n=73 Participants
A single dose of Reference Nicotine Gum (4 mg) to be chewed.
|
|---|---|---|---|---|
|
Area Under Concentration-time Curve From Time 0 Extrapolated to ∞ [AUC(0-∞)] of Nicotine 2 mg Test and Reference Products, and Nicotine 4 mg Test and Reference Products
|
12.56 hr*ng/mL
Standard Deviation 4.409
|
11.20 hr*ng/mL
Standard Deviation 3.955
|
24.60 hr*ng/mL
Standard Deviation 7.845
|
22.64 hr*ng/mL
Standard Deviation 7.136
|
Adverse Events
Test Nicotine Gum (2 mg)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Reference Nicotine Gum (2 mg)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Test Nicotine Gum (4 mg)
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Reference Nicotine Gum (4 mg)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test Nicotine Gum (2 mg)
n=82 participants at risk
A single dose of Nicotine Mint Gum (2 mg) to be chewed.
|
Reference Nicotine Gum (2 mg)
n=77 participants at risk
A single dose of Reference Nicotine Gum (2 mg) to be chewed.
|
Test Nicotine Gum (4 mg)
n=79 participants at risk
A single dose of Nicotine Mint Gum (4 mg) to be chewed.
|
Reference Nicotine Gum (4 mg)
n=81 participants at risk
A single dose of Reference Nicotine Gum (4 mg) to be chewed.
|
|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
0.00%
0/82
|
1.3%
1/77 • Number of events 1
|
0.00%
0/79
|
0.00%
0/81
|
|
Eye disorders
Eye irritation
|
0.00%
0/82
|
0.00%
0/77
|
1.3%
1/79 • Number of events 1
|
0.00%
0/81
|
|
Eye disorders
Eye pain
|
0.00%
0/82
|
0.00%
0/77
|
0.00%
0/79
|
1.2%
1/81 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/82 • Number of events 1
|
0.00%
0/77
|
0.00%
0/79
|
2.5%
2/81 • Number of events 3
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/82
|
0.00%
0/77
|
2.5%
2/79 • Number of events 2
|
1.2%
1/81 • Number of events 2
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/82
|
1.3%
1/77 • Number of events 1
|
0.00%
0/79
|
0.00%
0/81
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/82
|
1.3%
1/77 • Number of events 1
|
0.00%
0/79
|
0.00%
0/81
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/82
|
0.00%
0/77
|
0.00%
0/79
|
1.2%
1/81 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/82
|
0.00%
0/77
|
1.3%
1/79 • Number of events 1
|
0.00%
0/81
|
|
Gastrointestinal disorders
Gingival bleeding
|
1.2%
1/82 • Number of events 1
|
0.00%
0/77
|
0.00%
0/79
|
0.00%
0/81
|
|
Gastrointestinal disorders
Gingival pain
|
1.2%
1/82 • Number of events 1
|
0.00%
0/77
|
0.00%
0/79
|
0.00%
0/81
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/82
|
0.00%
0/77
|
0.00%
0/79
|
1.2%
1/81 • Number of events 1
|
|
Gastrointestinal disorders
Mouth ulceration
|
1.2%
1/82 • Number of events 1
|
0.00%
0/77
|
0.00%
0/79
|
0.00%
0/81
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/82
|
2.6%
2/77 • Number of events 2
|
1.3%
1/79 • Number of events 1
|
1.2%
1/81 • Number of events 1
|
|
Gastrointestinal disorders
Toothache
|
1.2%
1/82 • Number of events 1
|
1.3%
1/77 • Number of events 1
|
0.00%
0/79
|
0.00%
0/81
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/82
|
0.00%
0/77
|
1.3%
1/79 • Number of events 1
|
1.2%
1/81 • Number of events 1
|
|
General disorders
Catheter site erythema
|
0.00%
0/82
|
1.3%
1/77 • Number of events 1
|
0.00%
0/79
|
0.00%
0/81
|
|
General disorders
Catheter site related reaction
|
0.00%
0/82
|
0.00%
0/77
|
2.5%
2/79 • Number of events 2
|
0.00%
0/81
|
|
General disorders
Chest pain
|
0.00%
0/82
|
0.00%
0/77
|
0.00%
0/79
|
1.2%
1/81 • Number of events 1
|
|
General disorders
Fatigue
|
2.4%
2/82 • Number of events 2
|
0.00%
0/77
|
0.00%
0/79
|
1.2%
1/81 • Number of events 1
|
|
General disorders
Feeling hot
|
0.00%
0/82
|
0.00%
0/77
|
0.00%
0/79
|
1.2%
1/81 • Number of events 1
|
|
General disorders
Vessel puncture site anaesthesia
|
0.00%
0/82
|
0.00%
0/77
|
1.3%
1/79 • Number of events 2
|
0.00%
0/81
|
|
General disorders
Vessel puncture site pain
|
1.2%
1/82 • Number of events 1
|
1.3%
1/77 • Number of events 1
|
0.00%
0/79
|
0.00%
0/81
|
|
Infections and infestations
Pharyngitis
|
1.2%
1/82 • Number of events 2
|
0.00%
0/77
|
0.00%
0/79
|
0.00%
0/81
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/82
|
1.3%
1/77 • Number of events 1
|
0.00%
0/79
|
1.2%
1/81 • Number of events 1
|
|
Nervous system disorders
Headache
|
2.4%
2/82 • Number of events 3
|
5.2%
4/77 • Number of events 4
|
6.3%
5/79 • Number of events 5
|
1.2%
1/81 • Number of events 1
|
|
Nervous system disorders
Presyncope
|
0.00%
0/82
|
1.3%
1/77 • Number of events 1
|
1.3%
1/79 • Number of events 1
|
0.00%
0/81
|
|
Psychiatric disorders
Abnormal dreams
|
1.2%
1/82 • Number of events 1
|
0.00%
0/77
|
0.00%
0/79
|
0.00%
0/81
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/82
|
1.3%
1/77 • Number of events 1
|
0.00%
0/79
|
0.00%
0/81
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/82
|
1.3%
1/77 • Number of events 1
|
0.00%
0/79
|
0.00%
0/81
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
1.2%
1/82 • Number of events 1
|
0.00%
0/77
|
0.00%
0/79
|
0.00%
0/81
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/82
|
1.3%
1/77 • Number of events 1
|
0.00%
0/79
|
0.00%
0/81
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/82
|
1.3%
1/77 • Number of events 1
|
0.00%
0/79
|
0.00%
0/81
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
1.2%
1/82 • Number of events 1
|
0.00%
0/77
|
0.00%
0/79
|
0.00%
0/81
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/82
|
0.00%
0/77
|
1.3%
1/79 • Number of events 1
|
0.00%
0/81
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/82
|
0.00%
0/77
|
0.00%
0/79
|
1.2%
1/81 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/82
|
0.00%
0/77
|
1.3%
1/79 • Number of events 1
|
1.2%
1/81 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/82
|
0.00%
0/77
|
0.00%
0/79
|
1.2%
1/81 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
1.2%
1/82 • Number of events 1
|
0.00%
0/77
|
0.00%
0/79
|
0.00%
0/81
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.2%
1/82 • Number of events 1
|
0.00%
0/77
|
1.3%
1/79 • Number of events 1
|
0.00%
0/81
|
|
Vascular disorders
Hot flush
|
1.2%
1/82 • Number of events 1
|
0.00%
0/77
|
0.00%
0/79
|
1.2%
1/81 • Number of events 1
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER