Trial Outcomes & Findings for 28 Day Repeat Dose in Cystic Fibrosis Patients (NCT NCT00903201)

Last Updated: 2017-11-17

Results Overview

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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. 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, or is a congenital anomaly/birth defect or is medically significant.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

146 participants

Primary outcome timeframe

Up to Follow-up (up to 42 days)

Results posted on

2017-11-17

Participant Flow

This study was conducted at 16 centers in the United States of America, 6 centers in Germany, 5 centers in France, 3 centers in Israel and 1 center in Canada from 28 September 2009 to 29 December 2010.

Participants were screened for a period of 28 days and at that time their eligibility for study inclusion was assessed. A total of 146 participants with cystic fibrosis were randomized to receive either 20 mg, 50 mg SB656933 or placebo orally for 28 days.

Participant milestones

Participant milestones
Measure	Placebo Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.	SB656933 20 mg Eligible participants received SB656933 20 milligrams (mg) tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.	SB656933 50 mg Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
Overall Study STARTED	61	44	41
Overall Study COMPLETED	56	38	39
Overall Study NOT COMPLETED	5	6	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.	SB656933 20 mg Eligible participants received SB656933 20 milligrams (mg) tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.	SB656933 50 mg Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
Overall Study Adverse Event	1	4	0
Overall Study Protocol Violation	2	1	0
Overall Study Lost to Follow-up	0	1	0
Overall Study Physician Decision	1	0	1
Overall Study Withdrawal by Subject	1	0	1

Baseline Characteristics

28 Day Repeat Dose in Cystic Fibrosis Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=61 Participants Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.	SB656933 20 mg n=44 Participants Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.	SB656933 50 mg n=41 Participants Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.	Total n=146 Participants Total of all reporting groups
Age, Continuous	29.5 Years STANDARD_DEVIATION 8.41 • n=5 Participants	32.9 Years STANDARD_DEVIATION 11.65 • n=7 Participants	31.3 Years STANDARD_DEVIATION 12.12 • n=5 Participants	31.0 Years STANDARD_DEVIATION 10.59 • n=4 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	16 Participants n=7 Participants	17 Participants n=5 Participants	55 Participants n=4 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	28 Participants n=7 Participants	24 Participants n=5 Participants	91 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) White	59 Participants n=5 Participants	43 Participants n=7 Participants	41 Participants n=5 Participants	143 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to Follow-up (up to 42 days)

Population: All Subjects population which comprised of all participants who received at least one dose of study medication.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.	SB656933 20 mg n=44 Participants Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.	SB656933 50 mg n=41 Participants Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) AE	46 Participants	32 Participants	32 Participants
Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE) SAE	2 Participants	2 Participants	2 Participants

PRIMARY outcome

Timeframe: Up to Follow-up (up to 42 days)

Population: All Subjects Population.

Vital signs included heart rate, systolic and diastolic blood pressure and body temperature. Prior to vital signs all participants rested for at least five minutes in the seated, semi-supine, or supine position. The choice of position was kept constant for the duration of the study. Any results falling outside the normal range were repeated at the discretion of the Investigator. Potential clinical concern range for systolic blood pressure: \<85 and \>160 millimeter of mercury (mmHg), for diastolic: \<45 and \>100 mmHg and heart rate: \<40 and \>110 beats per minute. Number of participants with vital signs of potential clinical importance are presented.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.	SB656933 20 mg n=44 Participants Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.	SB656933 50 mg n=41 Participants Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
Number of Participants With Vital Signs of Potential Clinical Importance	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Follow-up (up to 42 days)

Population: All Subjects Population.

Hematology parameters were reviewed prior to participants receiving first dose of study medication. The potential clinical concern range for hematology parameters were: Red blood cell (RBC) count (low: \< 3.72 \* 10\^12/Liters (L) and high: \> 6.313 \* 10\^12/L), lymphocytes (low: \< 0.8 gigacells/L), hematocrit (low: \> 0.075 ratio change from Baseline and high: \> 0.54 ratio), mean cell hemoglobin (MCH) (low: \< 23.8 picograms (pg) and high: \> 39.6 pg), mean cell volume (MCV) (low: \<73 femtoliters (FL) and high: \>110 FL), platelet count (low: \< 100 gigacells/L and high: \> 550 gigacells/L), white blood cell (WBC) count (low: \< 3 gigacells/L and high: \> 20 gigacells/L) and eosinophils (high: \> 1 gigacells/L). Only those parameters for which at least one value of potential clinical concern was reported are summarized. Number of participants with hematology abnormalities of potential clinical importance are presented.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.	SB656933 20 mg n=44 Participants Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.	SB656933 50 mg n=41 Participants Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
Number of Participants With Hematology Abnormalities of Potential Clinical Importance Low RBC	2 Participants	1 Participants	0 Participants
Number of Participants With Hematology Abnormalities of Potential Clinical Importance High RBC	1 Participants	0 Participants	0 Participants
Number of Participants With Hematology Abnormalities of Potential Clinical Importance Low lymphocytes	2 Participants	0 Participants	1 Participants
Number of Participants With Hematology Abnormalities of Potential Clinical Importance Low Hematocrit	1 Participants	0 Participants	0 Participants
Number of Participants With Hematology Abnormalities of Potential Clinical Importance High Eosinophils	0 Participants	1 Participants	0 Participants
Number of Participants With Hematology Abnormalities of Potential Clinical Importance Low MCH	2 Participants	0 Participants	0 Participants
Number of Participants With Hematology Abnormalities of Potential Clinical Importance Low MCV	2 Participants	0 Participants	0 Participants
Number of Participants With Hematology Abnormalities of Potential Clinical Importance High platelet count	1 Participants	0 Participants	0 Participants
Number of Participants With Hematology Abnormalities of Potential Clinical Importance High WBC	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Follow-up (up to 42 days)

Population: All Subjects Population.

The potential clinical concern range for clinical chemistry parameters were: glucose (low: \< 2.8 millimole \[mmol\]/L and high: \> 9.4 mmol/L), creatine kinase (high: \> 3 \* upper limit of normal units \[ULN\]/L), phosphorous, inorganic (low: \< 0.8 mmol/L and high: \> 1.6 mmol/L), total bilirubin (high: ≥ 1.5 \* ULN micromole \[μmol\]/L), uric acid (low: \< 41.636 μmol/L and high: \> 582.904 μmol/L), alkaline phosphatase (ALP) (high: ≥ 2 \* ULN international units \[IU/L\]/L), gamma glutamyl transpeptidase (GGT) (high: ≥ 110 IU/L), carbon dioxide content (low: \< 18 mmol/L and high: \> 32 mmol/L), direct bilirubin (high: \> 1.5 \* ULN μmol/L), potassium (low: \< 3.0 mmol/L and high: \> 5.5 mmol/L) and aspartate aminotransferase (AST) (high: ≥ 3\* ULN IU/L). Only those parameters for which at least one value of potential clinical concern was reported are summarized. Number of participants with clinical chemistry abnormalities of potential clinical importance.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.	SB656933 20 mg n=44 Participants Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.	SB656933 50 mg n=41 Participants Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance High Creatine Kinase	2 Participants	0 Participants	2 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance High Phosphorous, inorganic	4 Participants	0 Participants	2 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance High Total Bilirubin	2 Participants	2 Participants	0 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance High Uric acid	4 Participants	2 Participants	4 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance High ALP	3 Participants	1 Participants	2 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance High GGT	3 Participants	1 Participants	2 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance Low CO2	3 Participants	3 Participants	4 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance High Direct Bilirubin	1 Participants	0 Participants	0 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance High Potassium	0 Participants	1 Participants	1 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance High AST	0 Participants	0 Participants	1 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance High Glucose	10 Participants	12 Participants	7 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance Low Glucose	3 Participants	4 Participants	3 Participants
Number of Participants With Clinical Chemistry Abnormalities of Potential Clinical Importance Low Phosphorous, inorganic	2 Participants	6 Participants	4 Participants

PRIMARY outcome

Timeframe: Up to Follow-up (up to 42 days)

Population: All Subjects Population.

Prior to ECG recordings, all participants rested for at least 5 minutes in the seated, semi-supine, or supine position. The choice of position was kept constant for the duration of the study. Participants avoided hot and cold food for at least 30 minutes prior to an ECG measurement. Any results falling outside normal range were repeated at the discretion of the Investigator. ECG Baseline values taken within 2.5 hours prior to first dose were calculated using the mean value of triplicate pre-dose readings. Triplicate readings were taken at least five minutes apart. Participants agreed to abstain from hot and cold drinks and food prior to an ECG measurement. ECG machine calculated heart rate and measured PR, QRS, QT, and QT corrected by Bazett's formula (QTcB), QT corrected by Fridericia's formula (QTcF) intervals. Number of participants with abnormal (not clinically significant \[NCS\] and clinically significant \[CS\]) electrocardiogram (ECG) findings are presented.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.	SB656933 20 mg n=44 Participants Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.	SB656933 50 mg n=41 Participants Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 1/Pre-dose 1, Abnormal-NCS	9 Participants	1 Participants	8 Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 1/Pre-dose 1, Abnormal-CS	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 1/Pre-dose 2, Abnormal-CS	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 1/Pre-dose 3, Abnormal-CS	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 14/Pre-dose 1, Abnormal-NCS	6 Participants	2 Participants	6 Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 14/Pre-dose 1, Abnormal-CS	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 28/Pre-dose 1, Abnormal-NCS	10 Participants	3 Participants	3 Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 28/Pre-dose 1, Abnormal-CS	0 Participants	0 Participants	0 Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 1/Pre-dose 2, Abnormal-NCS	9 Participants	0 Participants	6 Participants
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Day 1/Pre-dose 3, Abnormal-NCS	9 Participants	0 Participants	6 Participants

PRIMARY outcome

Timeframe: Day 1 to Day 42

Population: All Subjects Population.

CF is one of the most common, lethal, autosomal recessive disease characterized by airway obstruction, bronchiectasis and infection, and exocrine pancreatic insufficiency. Number of participants with CF exacerbation are presented.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.	SB656933 20 mg n=44 Participants Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.	SB656933 50 mg n=41 Participants Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
Number of Participants With Cystic Fibrosis (CF) Exacerbation	8 Participants	4 Participants	7 Participants

SECONDARY outcome

Timeframe: Day 1 and Day 28

Bacterial colony count of both Pseudomonas aeruginosa and Staphylococcus aureus in sputum were performed. Participants were graded as no bacteria in sputum, 1+, 2+, 3+ and 4+, which indicated proportional concentration of Pseudomonas aeruginosa and Staphylococcus aureus in sputum, where no bacteria indicated there was no bacteria in sputum, 1+ indicated slightly positive and 4+ indicated highly positive. Higher grades (4+) indicated worst outcomes (highly infected sputum). Number of participants with Pseudomonas aeruginosa and staphylococcus aureus count in sputum are presented.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.	SB656933 20 mg n=44 Participants Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.	SB656933 50 mg n=41 Participants Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum Staphylococcus aureus: Day 28, 2+	6 Participants	3 Participants	5 Participants
Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum Pseudomonas aeruginosa: Day 1, No bacteria	41 Participants	26 Participants	26 Participants
Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum Pseudomonas aeruginosa: Day 1, 1+	0 Participants	0 Participants	4 Participants
Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum Pseudomonas aeruginosa: Day 1, 2+	8 Participants	6 Participants	3 Participants
Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum Pseudomonas aeruginosa: Day 1, 3+	8 Participants	3 Participants	5 Participants
Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum Pseudomonas aeruginosa: Day 1, 4+	1 Participants	3 Participants	0 Participants
Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum Pseudomonas aeruginosa: Day 1, No sample	3 Participants	6 Participants	3 Participants
Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum Pseudomonas aeruginosa: Day 28, No bacteria	39 Participants	20 Participants	29 Participants
Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum Pseudomonas aeruginosa: Day 28, 1+	0 Participants	1 Participants	0 Participants
Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum Pseudomonas aeruginosa: Day 28, 2+	8 Participants	8 Participants	3 Participants
Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum Pseudomonas aeruginosa: Day 28, 3+	5 Participants	5 Participants	2 Participants
Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum Pseudomonas aeruginosa: Day 28, 4+	2 Participants	1 Participants	2 Participants
Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum Pseudomonas aeruginosa: Day 28, No sample	7 Participants	9 Participants	5 Participants
Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum Staphylococcus aureus: Day 1, No bacteria	32 Participants	20 Participants	20 Participants
Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum Staphylococcus aureus: Day 1, 1+	7 Participants	4 Participants	3 Participants
Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum Staphylococcus aureus: Day 1, 2+	7 Participants	7 Participants	1 Participants
Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum Staphylococcus aureus: Day 1, 3+	7 Participants	3 Participants	8 Participants
Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum Staphylococcus aureus: Day 1, 4+	5 Participants	4 Participants	6 Participants
Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum Staphylococcus aureus: Day 1, No sample	3 Participants	6 Participants	3 Participants
Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum Staphylococcus aureus: Day 28, No bacteria	35 Participants	18 Participants	17 Participants
Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum Staphylococcus aureus: Day 28, 1+	1 Participants	3 Participants	4 Participants
Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum Staphylococcus aureus: Day 28, 3+	10 Participants	10 Participants	4 Participants
Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum Staphylococcus aureus: Day 28, 4+	2 Participants	1 Participants	6 Participants
Number of Participants With Pseudomonas Aeruginosa and Staphylococcus Aureus Count in Sputum Staphylococcus aureus: Day 28, No sample	7 Participants	9 Participants	5 Participants

SECONDARY outcome

Timeframe: Day 28

Population: All Subjects Population. Only those participants available at the specified time points were analyzed.

Sputum samples were taken after bronchodilation and number of neutrophils in induced sputum were reported.

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.	SB656933 20 mg n=35 Participants Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.	SB656933 50 mg n=34 Participants Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
Induced Sputum Neutrophil Number	8640.0 10^4 cells/gram Geometric Coefficient of Variation 124.4	10496.2 10^4 cells/gram Geometric Coefficient of Variation 117.5	6265.4 10^4 cells/gram Geometric Coefficient of Variation 202.0

SECONDARY outcome

Timeframe: Day 28

Population: All Subjects Population. Only those participants available at the specified time points were analyzed.

Sputum samples were taken after bronchodilation and percentage of neutrophils in induced sputum are presented.

Outcome measures

Outcome measures
Measure	Placebo n=49 Participants Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.	SB656933 20 mg n=35 Participants Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.	SB656933 50 mg n=34 Participants Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
Induced Sputum Neutrophil Percentage	91.72 Percentage of neutrophil cells Standard Deviation 4.268	91.16 Percentage of neutrophil cells Standard Deviation 4.614	90.83 Percentage of neutrophil cells Standard Deviation 7.860

SECONDARY outcome

Timeframe: Day 28

Population: All Subjects Population. Only those participants available at the specified time points were analyzed.

Sputum samples were taken after bronchodilation. Mean induced sputum inflammatory markers namely Myeloperoxidase and neutrophil elastase are presented.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.	SB656933 20 mg n=44 Participants Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.	SB656933 50 mg n=41 Participants Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
Induced Sputum Inflammatory Markers-Myeloperoxidase and Neutrophil Elastase Myeloperoxidase	23.2814 Nanogram/microgram Geometric Coefficient of Variation 78.8	23.4163 Nanogram/microgram Geometric Coefficient of Variation 62.3	19.6353 Nanogram/microgram Geometric Coefficient of Variation 104.7
Induced Sputum Inflammatory Markers-Myeloperoxidase and Neutrophil Elastase Neutrophil elastase	11.2362 Nanogram/microgram Geometric Coefficient of Variation 276.4	16.5978 Nanogram/microgram Geometric Coefficient of Variation 113.3	8.7876 Nanogram/microgram Geometric Coefficient of Variation 361.5

SECONDARY outcome

Timeframe: Day 14 and Day 28

Population: All Subjects Population. Only those participants available at the specified time points were analyzed.

Blood samples intended for CC-16 and CXCL8 were collected in 5.0 milliliter (mL) serum separator goldtopped blood collection tubes, then immediately mixed by gentle inversion 10 times. The samples were permitted to coagulate for 30 to 60 minutes before centrifugation at 1600 g for 15 minutes. Two 0.75 mL aliquots of serum supernatant were transferred separately into two Sarstedt tubes and frozen at -70 degree Celsius (°C). Plasma samples intended for CC-16 and CXCL8 were centrally analyzed using a commercial test kit based on enzyme-linked immunosorbent assay (ELISA) method.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.	SB656933 20 mg n=44 Participants Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.	SB656933 50 mg n=41 Participants Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
Serum and Plasma Markers of Inflammation- Clara Cell Secretory Protein (CC-16) and CXCL8 (Interleukin-8 [IL-8]) CC-16: Day 14	5148.2 Picogram per milliliter Geometric Coefficient of Variation 55.0	5507.8 Picogram per milliliter Geometric Coefficient of Variation 56.3	5610.4 Picogram per milliliter Geometric Coefficient of Variation 46.9
Serum and Plasma Markers of Inflammation- Clara Cell Secretory Protein (CC-16) and CXCL8 (Interleukin-8 [IL-8]) CC-16: Day 28	5497.6 Picogram per milliliter Geometric Coefficient of Variation 59.2	5818.1 Picogram per milliliter Geometric Coefficient of Variation 63.7	6012.9 Picogram per milliliter Geometric Coefficient of Variation 49.7
Serum and Plasma Markers of Inflammation- Clara Cell Secretory Protein (CC-16) and CXCL8 (Interleukin-8 [IL-8]) CXCL8 (IL-8): Day 14	12.09 Picogram per milliliter Geometric Coefficient of Variation 54.6	15.75 Picogram per milliliter Geometric Coefficient of Variation 57.6	23.24 Picogram per milliliter Geometric Coefficient of Variation 68.4
Serum and Plasma Markers of Inflammation- Clara Cell Secretory Protein (CC-16) and CXCL8 (Interleukin-8 [IL-8]) CXCL8 (IL-8): Day 28	10.89 Picogram per milliliter Geometric Coefficient of Variation 66.9	15.68 Picogram per milliliter Geometric Coefficient of Variation 42.0	19.98 Picogram per milliliter Geometric Coefficient of Variation 53.8

SECONDARY outcome

Timeframe: Day 14 and Day 28

Population: All Subjects Population. Only those participants available at the specified time points were analyzed.

Blood samples intended for C-Reactive Protein (CRP) analysis were collected in 4.0 mL plain red-topped blood collection tubes. The samples were permitted to coagulate for 30 to 60 minutes before centrifugation at 1600 gram (g) for 15 minutes. A 1 mL volume of serum supernatant was transferred via pipette into a Nunc tube and stored at room temperature. Central analysis of CRP in serum samples was measured via fixed time nephelometry on the Behring Nephelometer II.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.	SB656933 20 mg n=44 Participants Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.	SB656933 50 mg n=41 Participants Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
Serum and Plasma Markers of Inflammation- C-reactive Protein (CRP) Day 28	3.29 Milligram per liter Geometric Coefficient of Variation 231.2	2.88 Milligram per liter Geometric Coefficient of Variation 231.1	5.67 Milligram per liter Geometric Coefficient of Variation 187.3
Serum and Plasma Markers of Inflammation- C-reactive Protein (CRP) Day 14	3.37 Milligram per liter Geometric Coefficient of Variation 229.0	2.72 Milligram per liter Geometric Coefficient of Variation 250.2	5.44 Milligram per liter Geometric Coefficient of Variation 204.2

SECONDARY outcome

Timeframe: Day 14 and Day 28

Population: All Subjects Population. Only those participants available at the specified time points were analyzed. One participant in the SB656933 20 mg arm had a fibrinogen reading on Day 14. This was not a planned visit schedule, therefore, fibrinogen levels were not analyzed for the placebo arm and SB656933 50 mg arm.

Blood samples intended for fibrinogen analysis were collected in 4.5 mL 3.2 % sodium citrate blue-topped blood collection tubes, then immediately mixed by gentle inversion eight to ten times. Each sample was centrifuged at 1600 g for 15 minutes. A 1 mL volume of plasma supernatant was transferred via pipette into a Nunc tube, frozen at -20°C. Central analysis of fibrinogen in plasma samples was completed via photometric clot detection with automatic sample preparation.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.	SB656933 20 mg n=44 Participants Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.	SB656933 50 mg n=41 Participants Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
Serum and Plasma Markers of Inflammation- Fibrinogen Day 14	—	2.240 Gram per liter Geometric Coefficient of Variation NA Single participant	—
Serum and Plasma Markers of Inflammation- Fibrinogen Day 28	3.442 Gram per liter Geometric Coefficient of Variation 24.1	3.259 Gram per liter Geometric Coefficient of Variation 25.5	3.717 Gram per liter Geometric Coefficient of Variation 20.5

SECONDARY outcome

Timeframe: Day 14 and Day 28

Population: All Subjects Population. Only those participants available at the specified time points were analyzed.

Blood samples intended for MMP-8 and MMP-9 analyses were collected in 4.0 mL lithium heparin greentopped collection tubes, then immediately mixed by gentle inversion five times. The samples were centrifuged at 1800 g for 15 minutes within 30 minutes of collection. A 2 mL volume of supernatant was transferred into a Sarstedt tube and subsequently centrifuged at 10000 g for 10 minutes at 2 to 8°C for complete platelet removal. A 1 mL volume of plasma supernatant was transferred into a Sarstedt tube and frozen at -70°C. Blood samples intended for SP-D were collected in 5.0 mL serum separator goldtopped blood collection tubes, then immediately mixed by gentle inversion 10 times. The samples were permitted to coagulate for 30 to 60 minutes before centrifugation at 1600 g for 15 minutes. Two 0.75 mL aliquots of serum supernatant were transferred separately into two Sarstedt tubes and frozen at -70°C. Plasma samples were centrally analyzed using a commercial test kit based on ELISA method.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.	SB656933 20 mg n=44 Participants Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.	SB656933 50 mg n=41 Participants Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
Serum and Plasma Markers of Inflammation- Matrix Metalloproteinase-8 (MMP8), Matrix Metalloproteinase-9 (MMP9) and Surfactant Protein D (SP-D) MMP8: Day 28	10.136 Nanogram per milliliter Geometric Coefficient of Variation 113.2	9.188 Nanogram per milliliter Geometric Coefficient of Variation 137.7	9.043 Nanogram per milliliter Geometric Coefficient of Variation 119.0
Serum and Plasma Markers of Inflammation- Matrix Metalloproteinase-8 (MMP8), Matrix Metalloproteinase-9 (MMP9) and Surfactant Protein D (SP-D) MMP9: Day 14	122.31 Nanogram per milliliter Geometric Coefficient of Variation 104.8	107.40 Nanogram per milliliter Geometric Coefficient of Variation 81.6	85.72 Nanogram per milliliter Geometric Coefficient of Variation 93.4
Serum and Plasma Markers of Inflammation- Matrix Metalloproteinase-8 (MMP8), Matrix Metalloproteinase-9 (MMP9) and Surfactant Protein D (SP-D) MMP9: Day 28	116.31 Nanogram per milliliter Geometric Coefficient of Variation 87.1	115.32 Nanogram per milliliter Geometric Coefficient of Variation 89.4	106.60 Nanogram per milliliter Geometric Coefficient of Variation 107.4
Serum and Plasma Markers of Inflammation- Matrix Metalloproteinase-8 (MMP8), Matrix Metalloproteinase-9 (MMP9) and Surfactant Protein D (SP-D) SP-D: Day 14	10.707 Nanogram per milliliter Geometric Coefficient of Variation 76.8	9.735 Nanogram per milliliter Geometric Coefficient of Variation 88.3	9.367 Nanogram per milliliter Geometric Coefficient of Variation 74.2
Serum and Plasma Markers of Inflammation- Matrix Metalloproteinase-8 (MMP8), Matrix Metalloproteinase-9 (MMP9) and Surfactant Protein D (SP-D) SP-D: Day 28	10.428 Nanogram per milliliter Geometric Coefficient of Variation 80.6	10.037 Nanogram per milliliter Geometric Coefficient of Variation 90.7	10.042 Nanogram per milliliter Geometric Coefficient of Variation 67.9
Serum and Plasma Markers of Inflammation- Matrix Metalloproteinase-8 (MMP8), Matrix Metalloproteinase-9 (MMP9) and Surfactant Protein D (SP-D) MMP8: Day 14	11.407 Nanogram per milliliter Geometric Coefficient of Variation 109.0	8.808 Nanogram per milliliter Geometric Coefficient of Variation 136.5	7.626 Nanogram per milliliter Geometric Coefficient of Variation 143.3

SECONDARY outcome

Timeframe: Baseline (Day 1) to Day 14 and Day 28

Population: All Subjects Population. Only those participants available at the specified time points were analyzed.

FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. The change from Baseline was calculated by subtracting the Baseline values from the individual post-randomization values.

Outcome measures

Outcome measures
Measure	Placebo n=61 Participants Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.	SB656933 20 mg n=44 Participants Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.	SB656933 50 mg n=41 Participants Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) FEV1: Day 14	0.040 L Interval -0.02 to 0.101	-0.065 L Interval -0.138 to 0.007	-0.036 L Interval -0.108 to 0.036
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) FEV1: Day 28	0.031 L Interval -0.026 to 0.087	-0.031 L Interval -0.099 to 0.037	-0.013 L Interval -0.08 to 0.054
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) FVC: Day 14	-0.005 L Interval -0.069 to 0.058	-0.072 L Interval -0.148 to 0.005	-0.017 L Interval -0.092 to 0.059
Change From Baseline in Forced Expiratory Volume in One Second (FEV1) and Forced Vital Capacity (FVC) FVC: Day 28	-0.018 L Interval -0.085 to 0.048	-0.021 L Interval -0.101 to 0.059	0.022 L Interval -0.056 to 0.101

SECONDARY outcome

Timeframe: Day 1: pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose and Day 28: pre-dose, 1 and 4 hours

Population: PK Population which comprised of all participants in the 'All Subjects' population for whom a pharmacokinetic sample was obtained and analyzed.

Blood samples were taken via an indwelling cannula (or by direct venepuncture), collected into a 3.0 mL Ethylenediaminetetraacetic acid (EDTA) lavender-topped collection tube, immediately mixed by gentle inversion ten times, then placed on water ice. The samples were centrifuged at 1600 g for 15 minutes at 4°C for 10 minutes. Supernatant plasma was transferred to a 1.8 mL Nunc tube and frozen at -20°C.

Outcome measures

Outcome measures
Measure	Placebo n=44 Participants Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.	SB656933 20 mg n=41 Participants Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.	SB656933 50 mg Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
Area Under the Plasma Drug Concentration (AUC) Versus Time Curve: AUC From Time Zero (Pre-dose) to Four Hours Post Dose (AUC[0-4]) and AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-t]) AUC(0-4): Day 1	747.1 Nanogram * hour/milliliter (ng*h/mL) Geometric Coefficient of Variation 63.8	2227.6 Nanogram * hour/milliliter (ng*h/mL) Geometric Coefficient of Variation 44.8	—
Area Under the Plasma Drug Concentration (AUC) Versus Time Curve: AUC From Time Zero (Pre-dose) to Four Hours Post Dose (AUC[0-4]) and AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-t]) AUC(0-4): Day 28	592.3 Nanogram * hour/milliliter (ng*h/mL) Geometric Coefficient of Variation 93.1	1906.8 Nanogram * hour/milliliter (ng*h/mL) Geometric Coefficient of Variation 85.1	—
Area Under the Plasma Drug Concentration (AUC) Versus Time Curve: AUC From Time Zero (Pre-dose) to Four Hours Post Dose (AUC[0-4]) and AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-t]) AUC(0-t): Day 1	1272.5 Nanogram * hour/milliliter (ng*h/mL) Geometric Coefficient of Variation 42.6	3537.6 Nanogram * hour/milliliter (ng*h/mL) Geometric Coefficient of Variation 45.0	—
Area Under the Plasma Drug Concentration (AUC) Versus Time Curve: AUC From Time Zero (Pre-dose) to Four Hours Post Dose (AUC[0-4]) and AUC From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC[0-t]) AUC(0-t): Day 28	592.3 Nanogram * hour/milliliter (ng*h/mL) Geometric Coefficient of Variation 93.1	1906.8 Nanogram * hour/milliliter (ng*h/mL) Geometric Coefficient of Variation 85.1	—

SECONDARY outcome

Timeframe: Day 1: pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose and Day 28: pre-dose, 1 and 4 hours

Population: PK population. Only those participants available at the specified time points were analyzed.

Blood samples were taken via an indwelling cannula (or by direct venepuncture), collected into a 3.0 mL EDTA lavender-topped collection tube, immediately mixed by gentle inversion ten times, then placed on water ice. The samples were centrifuged at 1600 g for 15 minutes at 4°C for 10 minutes. Supernatant plasma was transferred to a 1.8 mL Nunc tube and frozen at -20°C.

Outcome measures

Outcome measures
Measure	Placebo n=44 Participants Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.	SB656933 20 mg n=41 Participants Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.	SB656933 50 mg Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
Maximum Observed Plasma Drug Concentration (Cmax) Day 1	342.89 Nanogram per milliliter Geometric Coefficient of Variation 53.6	967.78 Nanogram per milliliter Geometric Coefficient of Variation 54.3	—
Maximum Observed Plasma Drug Concentration (Cmax) Day 28	222.86 Nanogram per milliliter Geometric Coefficient of Variation 122.4	778.04 Nanogram per milliliter Geometric Coefficient of Variation 65.2	—

SECONDARY outcome

Timeframe: Day 1: pre-dose, 0.5, 1, 2, 4 and 8 hours post-dose and Day 28: pre-dose, 1 and 4 hours

Population: PK population. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	Placebo n=44 Participants Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.	SB656933 20 mg n=41 Participants Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.	SB656933 50 mg Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
Time to Maximum Observed Plasma Drug Concentration (Tmax) Day 28	2.1101 Hour Interval 0.967 to 4.083	1.8449 Hour Interval 0.95 to 4.0	—
Time to Maximum Observed Plasma Drug Concentration (Tmax) Day 1	1.9398 Hour Interval 0.5 to 4.0	1.7362 Hour Interval 0.5 to 4.25	—

Adverse Events

Placebo

Serious events: 2 serious events

Other events: 33 other events

Deaths: 0 deaths

SB656933 20 mg

Serious events: 2 serious events

Other events: 28 other events

Deaths: 0 deaths

SB656933 50 mg

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=61 participants at risk Eligible participants received SB656933 matching placebo tablets via oral route, two tablets each morning, for a total of 28 days.	SB656933 20 mg n=44 participants at risk Eligible participants received SB656933 20 mg tablets (two tablets of 10 mg each, every morning) via oral route, for a total of 28 days.	SB656933 50 mg n=41 participants at risk Eligible participants received two tablets (one tablet of SB656933 50 mg and one SB656933 matching placebo tablet) each morning, via oral route, for a total of 28 days.
Infections and infestations Infective pulmonary exacerbation of cystic fibrosis	3.3% 2/61 • Serious adverse events (SAE) and non-serious adverse events (nSAE) were collected from the first administration of study medication (Day 1) until the final follow up visit (Day 42, Visit 6). SAE and nSAE are reported for all subjects population which comprised of all participants who received at least one dose of study medication.	2.3% 1/44 • Serious adverse events (SAE) and non-serious adverse events (nSAE) were collected from the first administration of study medication (Day 1) until the final follow up visit (Day 42, Visit 6). SAE and nSAE are reported for all subjects population which comprised of all participants who received at least one dose of study medication.	2.4% 1/41 • Serious adverse events (SAE) and non-serious adverse events (nSAE) were collected from the first administration of study medication (Day 1) until the final follow up visit (Day 42, Visit 6). SAE and nSAE are reported for all subjects population which comprised of all participants who received at least one dose of study medication.
Infections and infestations Sinusitis	1.6% 1/61 • Serious adverse events (SAE) and non-serious adverse events (nSAE) were collected from the first administration of study medication (Day 1) until the final follow up visit (Day 42, Visit 6). SAE and nSAE are reported for all subjects population which comprised of all participants who received at least one dose of study medication.	0.00% 0/44 • Serious adverse events (SAE) and non-serious adverse events (nSAE) were collected from the first administration of study medication (Day 1) until the final follow up visit (Day 42, Visit 6). SAE and nSAE are reported for all subjects population which comprised of all participants who received at least one dose of study medication.	0.00% 0/41 • Serious adverse events (SAE) and non-serious adverse events (nSAE) were collected from the first administration of study medication (Day 1) until the final follow up visit (Day 42, Visit 6). SAE and nSAE are reported for all subjects population which comprised of all participants who received at least one dose of study medication.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/61 • Serious adverse events (SAE) and non-serious adverse events (nSAE) were collected from the first administration of study medication (Day 1) until the final follow up visit (Day 42, Visit 6). SAE and nSAE are reported for all subjects population which comprised of all participants who received at least one dose of study medication.	2.3% 1/44 • Serious adverse events (SAE) and non-serious adverse events (nSAE) were collected from the first administration of study medication (Day 1) until the final follow up visit (Day 42, Visit 6). SAE and nSAE are reported for all subjects population which comprised of all participants who received at least one dose of study medication.	0.00% 0/41 • Serious adverse events (SAE) and non-serious adverse events (nSAE) were collected from the first administration of study medication (Day 1) until the final follow up visit (Day 42, Visit 6). SAE and nSAE are reported for all subjects population which comprised of all participants who received at least one dose of study medication.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/61 • Serious adverse events (SAE) and non-serious adverse events (nSAE) were collected from the first administration of study medication (Day 1) until the final follow up visit (Day 42, Visit 6). SAE and nSAE are reported for all subjects population which comprised of all participants who received at least one dose of study medication.	0.00% 0/44 • Serious adverse events (SAE) and non-serious adverse events (nSAE) were collected from the first administration of study medication (Day 1) until the final follow up visit (Day 42, Visit 6). SAE and nSAE are reported for all subjects population which comprised of all participants who received at least one dose of study medication.	2.4% 1/41 • Serious adverse events (SAE) and non-serious adverse events (nSAE) were collected from the first administration of study medication (Day 1) until the final follow up visit (Day 42, Visit 6). SAE and nSAE are reported for all subjects population which comprised of all participants who received at least one dose of study medication.

Other adverse events

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