Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Ye... | NCT00953706

ID	Type	Description	Link
2009-010261-23	EudraCT Number

Name	Class
Cystic Fibrosis Foundation	OTHER

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo matched to ivacaftor tablet orally every 12 hours (q12h) for 16 weeks during Part A (double-blind treatment period), followed by ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).	Drug: Ivacaftor Drug: Placebo
Ivacaftor	Experimental	Ivacaftor 150 milligram (mg) tablet orally q12h for 16 weeks during Part A (double-blind treatment period), followed by ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).	Drug: Ivacaftor

Name	Type	Description	Arm Group Labels	Other Names
Ivacaftor	Drug	Tablet	Ivacaftor Placebo	VX-770

Measure	Description	Time Frame
Part A : Absolute Change From Part A Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 16	Spirometry (as measured by ppFEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies. FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. ppFEV1 (predicted for age, gender, and height) was calculated using the Knudson method.	Part A baseline through Week 16

Measure	Description	Time Frame
Part A : Absolute Change From Part A Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 16	The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; Higher scores indicating fewer symptoms and better health-related quality of life.

Name	Affiliation	Role
Patrick A Flume, MD	Medical University of South Carolina	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama		Birmingham	Alabama	35294	United States
Providence Medical Center

PubMed Identifier	Type	Citation	Retractions
22383668	Derived	Flume PA, Liou TG, Borowitz DS, Li H, Yen K, Ordonez CL, Geller DE; VX 08-770-104 Study Group. Ivacaftor in subjects with cystic fibrosis who are homozygous for the F508del-CFTR mutation. Chest. 2012 Sep;142(3):718-724. doi: 10.1378/chest.11-2672.

Label	URL
Genetics Home Reference	View source

ID	Title	Description
FG000	Placebo - Part A	Placebo matched to ivacaftor tablet orally every 12 hours (q12h) for 16 weeks during Part A (double-blind treatment period).
FG001	Ivacaftor - Part A	Ivacaftor 150 milligram (mg) tablet orally q12h for 16 weeks during Part A (double-blind treatment period).

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Part A : Absolute Change From Part A Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) Through Week 16

Spirometry (as measured by ppFEV1) is a standardized assessment to evaluate lung function that is the most widely used endpoint in cystic fibrosis studies. FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. ppFEV1 (predicted for age, gender, and height) was calculated using the Knudson method.

Part A Full Analysis Set (FAS) included all randomized participants who received at least 1 dose of study drug during Part A. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

percent predicted of FEV1

Part A baseline through Week 16

ID	Title	Description
OG000	Placebo - Part A	Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
OG001	Ivacaftor - Part A	Ivacaftor 150 mg tablet orally q12h for 16 weeks during Part A (double-blind treatment period).

Units	Counts
Participants	OG00028 OG001111

Title

Denominators

Categories

Title	Measurements
	OG000-0.2± 1.1 OG0011.5± 0.5

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	The primary analysis for the primary efficacy variable was based on a Mixed-Effects Model for Repeated Measures (MMRM). The model included absolute change from baseline in percent predicted forced expiratory volume in 1 second (FEV1) as the dependent variable, treatment (ivacaftor versus placebo) and visit as fixed effects, and participant as a random effect, with adjustment for age and continuous baseline value of percent predicted FEV1.	Mixed Models Analysis		0.1509		Mean Difference (Final Values)	1.7	Standard Error of the Mean	1.2	2-Sided	95	-0.6	4.1				No	Superiority or Other

Secondary

Part A : Absolute Change From Part A Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 16

The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for participants with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; Higher scores indicating fewer symptoms and better health-related quality of life.

Part A FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

units on a scale

Part A baseline through Week 16

ID	Title	Description
OG000	Placebo - Part A	Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
OG001	Ivacaftor - Part A	Ivacaftor 150 mg tablet orally q12h for 16 weeks during Part A (double-blind treatment period).

Units	Counts
Participants

Secondary

Part A : Absolute Change From Part A Baseline in Sweat Chloride Concentration Through Week 16

The sweat chloride (quantitative pilocarpine iontophoresis) test is a standard diagnostic tool for cystic fibrosis (CF), serving as an indicator of cystic fibrosis transmembrane conductance regulator (CFTR) activity.

Part A FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

millimole per liter (mmol/L)

Part A baseline through Week 16

ID	Title	Description
OG000	Placebo - Part A	Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
OG001	Ivacaftor - Part A	Ivacaftor 150 mg tablet orally q12h for 16 weeks during Part A (double-blind treatment period).

Units	Counts
Participants	OG000

Secondary

Part A : Rate of Change From Baseline in Weight Through Week 16

As malnutrition is common in participants with cystic fibrosis (CF) because of increased energy expenditures due to lung disease and fat malabsorption, body weight is an important clinical measure of nutritional status.

Part A FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.

Posted

Least Squares Mean

Standard Error

kilograms per 112 days

Part A baseline through Week 16

ID	Title	Description
OG000	Placebo - Part A	Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
OG001	Ivacaftor - Part A	Ivacaftor 150 mg tablet orally q12h for 16 weeks during Part A (double-blind treatment period).

Units	Counts
Participants	OG000

Secondary

Part B : Absolute Change From Part A and Part B Baseline in ppFEV1 Through Week 64

ppFEV1 is defined in Outcome Measure 1.

Part B FAS included all participants who received at least 1 dose of study drug during Part B. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.

Posted

Mean

Standard Deviation

percent predicted of FEV1

Change from Part A baseline: Part A Baseline, Week 64; Change from Part B baseline: Part B Baseline (Week 16), Week 64

ID	Title	Description
OG000	Placebo/Ivacaftor - Part B	Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
OG001	Ivacaftor/Ivacaftor - Part B	Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).

Units	Counts
Participants

Secondary

Part B : Rate of Change From Part A Baseline in ppFEV1 Through Week 64

ppFEV1 is defined in Outcome Measure 1.

Part B FAS.

Posted

Least Squares Mean

Standard Error

percent predicted of FEV1 per 448 days

Part A baseline through Week 64

ID	Title	Description
OG000	Placebo/Ivacaftor - Part B	Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
OG001	Ivacaftor/Ivacaftor - Part B	Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).

Units	Counts
Participants	OG000

Secondary

Part B : Rate of Change From Part B Baseline in ppFEV1 Through Week 64

ppFEV1 is defined in Outcome Measure 1.

Part B FAS.

Posted

Least Squares Mean

Standard Error

percent predicted of FEV1 per 336 days

Part B baseline through Week 64

ID	Title	Description
OG000	Placebo/Ivacaftor - Part B	Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
OG001	Ivacaftor/Ivacaftor - Part B	Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).

Units	Counts
Participants	OG000

Secondary

Part B : Absolute Change From Part A and Part B Baseline in CFQ-R Respiratory Domain Score Through Week 64

Part B FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.

Posted

Mean

Standard Deviation

units on a scale

Change from Part A baseline: Part A Baseline, Week 64; Change from Part B baseline: Part B Baseline (Week 16), Week 64

ID	Title	Description
OG000	Placebo/Ivacaftor - Part B	Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
OG001	Ivacaftor/Ivacaftor - Part B	Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).

Units	Counts

Secondary

Part B : Absolute Change From Part A and Part B Baseline in Sweat Chloride Concentration Through Week 64

Part B FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.

Posted

Mean

Standard Deviation

mmol/L

Change from Part A baseline: Part A Baseline, Week 64; Change from Part B baseline: Part B Baseline (Week 16), Week 64

ID	Title	Description
OG000	Placebo/Ivacaftor - Part B	Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
OG001	Ivacaftor/Ivacaftor - Part B	Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).

Units	Counts
Participants

Secondary

Part B : Absolute Change From Part A and Part B Baseline in Weight Through Week 64

As malnutrition is common in patients with cystic fibrosis (CF) because of increased energy expenditures due to lung disease and fat malabsorption, body weight is an important clinical measure of nutritional status.

Part B FAS. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.

Posted

Mean

Standard Deviation

kilograms (kg)

Change from Part A baseline: Part A Baseline, Week 64; Change from Part B baseline: Part B Baseline (Week 16), Week 64

ID	Title	Description
OG000	Placebo/Ivacaftor - Part B	Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
OG001	Ivacaftor/Ivacaftor - Part B	Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).

Units	Counts
Participants

Secondary

Part B : Number of Participants With Pulmonary Exacerbations

Pulmonary exacerbation was defined as new, or changed, antibiotic therapy (intravenous, inhaled, or oral) for any 4 or more of the following signs/symptoms: change in sputum; new or increased hemoptysis; increased cough; increased dyspnea; malaise, fatigue, or lethargy; temperature above 38 degrees Celsius; anorexia or weight loss; sinus pain or tenderness; change in sinus discharge; change in physical examination of the chest; decrease in pulmonary function by 10 percent (%); and radiographic changes indicative of pulmonary infection.

Part B FAS.

Posted

Number

participants

Part B baseline through Week 64

ID	Title	Description
OG000	Placebo/Ivacaftor - Part B	Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
OG001	Ivacaftor/Ivacaftor - Part B	Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).

Units	Counts
Participants

Secondary

Part B : Number of Pulmonary Exacerbation Events

Part B FAS.

Posted

Number

events

Part B baseline through Week 64

ID	Title	Description
OG000	Placebo/Ivacaftor - Part B	Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
OG001	Ivacaftor/Ivacaftor - Part B	Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).

Units	Counts
Participants

Secondary

Part B : Number of Pulmonary Exacerbation Events Per Participant Per Year

Part B FAS.

Posted

Number

events per participant per year

Part B baseline through Week 64

ID	Title	Description
OG000	Placebo/Ivacaftor - Part B	Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
OG001	Ivacaftor/Ivacaftor - Part B	Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).

Units	Counts

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Cystic fibrosis lung	Congenital, familial and genetic disorders	MedDRA (12.0)	Systematic Assessment	CF exacerbations were coded as "cystic fibrosis lung."	EG0006 events5 affected28 at risk EG00112 events10 affected112 at risk EG0024 events2 affected5 at risk EG00320 events13 affected33 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0012 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Fatigue	General disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Bronchopneumonia	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Central line infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Lung infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Traumatic brain injury	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Cognitive disorder	Nervous system disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Depression	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Venous thrombosis	Vascular disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Cystic fibrosis lung	Congenital, familial and genetic disorders	MedDRA (12.0)	Systematic Assessment	CF exacerbations were coded as "cystic fibrosis lung."	EG0008 events7 affected28 at risk EG00124 events19 affected112 at risk EG0026 events3 affected5 at risk EG00317 events11 affected33 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0004 events1 affected28 at risk EG0018 events7 affected112 at risk EG0020 events0 affected5 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0002 events2 affected28 at risk EG0017 events6 affected112 at risk EG0020 events0 affected5 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG00111 events10 affected112 at risk EG0020 events0 affected5 at risk EG003
Chills	General disorders	MedDRA (12.0)	Systematic Assessment		EG0002 events2 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Fatigue	General disorders	MedDRA (12.0)	Systematic Assessment		EG0003 events3 affected28 at risk EG0018 events8 affected112 at risk EG0020 events0 affected5 at risk EG003
Pyrexia	General disorders	MedDRA (12.0)	Systematic Assessment		EG0002 events2 affected28 at risk EG00110 events9 affected112 at risk EG0020 events0 affected5 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Bronchitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Candidiasis	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Clostridium Difficile colitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0012 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Ear infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Folliculitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Hordeolum	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Influenza	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Kidney infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Laryngitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0015 events4 affected112 at risk EG0020 events0 affected5 at risk EG003
Oral candidiasis	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Oral herpes	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Orchitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Otitis media	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Pharyngitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Pharyngitis streptococcal	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Pneumonia staphylococcal	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Respiratory monilliasis	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Respiratory tract infection viral	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Rhinitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0015 events5 affected112 at risk EG0020 events0 affected5 at risk EG003
Sinusitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0019 events8 affected112 at risk EG0021 events1 affected5 at risk EG003
Stenotrophomonas infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Tinea infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Tooth abscess	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0002 events2 affected28 at risk EG00113 events11 affected112 at risk EG0021 events1 affected5 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Viral upper respiratory tract infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Vulvovaginal mycotic infection	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA (12.0)	Systematic Assessment		EG0003 events2 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA (12.0)	Systematic Assessment		EG0003 events2 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
C-reactive protein increased	Investigations	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0016 events6 affected112 at risk EG0020 events0 affected5 at risk EG003
Pulmonary function test decreased	Investigations	MedDRA (12.0)	Systematic Assessment		EG0002 events2 affected28 at risk EG0014 events3 affected112 at risk EG0020 events0 affected5 at risk EG003
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0002 events2 affected28 at risk EG0013 events3 affected112 at risk EG0020 events0 affected5 at risk EG003
Dizziness	Nervous system disorders	MedDRA (12.0)	Systematic Assessment		EG0002 events2 affected28 at risk EG0013 events2 affected112 at risk EG0020 events0 affected5 at risk EG003
Headache	Nervous system disorders	MedDRA (12.0)	Systematic Assessment		EG0003 events2 affected28 at risk EG00117 events11 affected112 at risk EG0020 events0 affected5 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment		EG0002 events2 affected28 at risk EG0011 events1 affected112 at risk EG0021 events1 affected5 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0002 events1 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Bronchospasm	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0005 events4 affected28 at risk EG00143 events34 affected112 at risk EG0020 events0 affected5 at risk EG003
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0021 events1 affected5 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0015 events5 affected112 at risk EG0021 events1 affected5 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Haemoptysis	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG00110 events5 affected112 at risk EG0023 events2 affected5 at risk EG003
Increased viscosity of bronchial secretion	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0002 events2 affected28 at risk EG00114 events13 affected112 at risk EG0020 events0 affected5 at risk EG003
Nasal mucosal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0013 events3 affected112 at risk EG0020 events0 affected5 at risk EG003
Nasal oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Nasal polyps	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0013 events3 affected112 at risk EG0020 events0 affected5 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0003 events3 affected28 at risk EG00112 events10 affected112 at risk EG0020 events0 affected5 at risk EG003
Paranasal sinus hypersecretion	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Pharyngeal disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Pharyngeal erythema	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0012 events2 affected112 at risk EG0020 events0 affected5 at risk EG003
Pleuritic pain	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Postnasal drip	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0019 events9 affected112 at risk EG0020 events0 affected5 at risk EG003
Rales	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0014 events3 affected112 at risk EG0020 events0 affected5 at risk EG003
Respiration abnormal	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0012 events2 affected112 at risk EG0021 events1 affected5 at risk EG003
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0014 events3 affected112 at risk EG0020 events0 affected5 at risk EG003
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0002 events2 affected28 at risk EG0015 events4 affected112 at risk EG0020 events0 affected5 at risk EG003
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0012 events2 affected112 at risk EG0020 events0 affected5 at risk EG003
Sputum discoloured	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0012 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Tachypnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Throat irritation	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0013 events3 affected112 at risk EG0020 events0 affected5 at risk EG003
Dermatitis contact	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0019 events6 affected112 at risk EG0020 events0 affected5 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0019 events9 affected112 at risk EG0020 events0 affected5 at risk EG003
Bacterial disease carrier	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Body tinea	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Cystitis	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Helicobacter gastritis	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0021 events1 affected5 at risk EG003
Infectious mononucleosis	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Otitis externa	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Pneumonia	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Vaginitis bacterial	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Vulvovaginal candidiasis	Infections and infestations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Blood glucose increased	Investigations	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0015 events5 affected112 at risk EG0020 events0 affected5 at risk EG003
Bacteria sputum identified	Investigations	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0014 events3 affected112 at risk EG0020 events0 affected5 at risk EG003
Prothrombin time prolonged	Investigations	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0013 events3 affected112 at risk EG0020 events0 affected5 at risk EG003
Gamma-glutamyl transferase increased	Investigations	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0012 events2 affected112 at risk EG0020 events0 affected5 at risk EG003
Glucose urine present	Investigations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0014 events3 affected112 at risk EG0020 events0 affected5 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0012 events2 affected112 at risk EG0020 events0 affected5 at risk EG003
Blood immunoglobulin G increased	Investigations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0012 events2 affected112 at risk EG0020 events0 affected5 at risk EG003
Breath sounds abnormal	Investigations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0012 events2 affected112 at risk EG0020 events0 affected5 at risk EG003
Forced expiratory volume decreased	Investigations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0012 events2 affected112 at risk EG0021 events1 affected5 at risk EG003
Vitamin D decreased	Investigations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0012 events2 affected112 at risk EG0020 events0 affected5 at risk EG003
White blood cell count increased	Investigations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0012 events2 affected112 at risk EG0020 events0 affected5 at risk EG003
Acivated partial thromboplastin time prolonged	Investigations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Antibiotic level above therapeutic	Investigations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Bacterial culture positive	Investigations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0012 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Blood alkaline phosphatase increased	Investigations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Blood glucose decreased	Investigations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0012 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Blood lactate dehydrogenase increased	Investigations	MedDRA (12.0)	Systematic Assessment		EG0002 events1 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Bone density decreased	Investigations	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Liver function test abnormal	Investigations	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Neutrophil count increased	Investigations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Platelet count decreased	Investigations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Sputum culture positive	Investigations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0012 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Weight decreased	Investigations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
White blood cell count decreased	Investigations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
International normalised ratio increased	Investigations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Oxygen saturation decreased	Investigations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Sputum abnormal	Investigations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Weight increased	Investigations	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0015 events4 affected112 at risk EG0023 events3 affected5 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0014 events4 affected112 at risk EG0020 events0 affected5 at risk EG003
Flatulence	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0012 events2 affected112 at risk EG0020 events0 affected5 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Aphthous stomatitis	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Ascites	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0021 events1 affected5 at risk EG003
Dental Caries	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Distal Ileal Obstruction Syndrome	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0012 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Dry Mouth	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Frequent Bowel Movements	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0012 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Gastrointestinal Hypomotility	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Gastrooesophageal Reflux Disease	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Hiatus Hernia	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Pancreatic Duct Dilatation	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Peptic Ulcer	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Regurgitation	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Tooth Impacted	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Toothache	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Distal Intestinal Obstruction Syndrome	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Sensitivity Of Teeth	Gastrointestinal disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Catheter Site Pain	General disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0012 events2 affected112 at risk EG0020 events0 affected5 at risk EG003
Application Site Pruritus	General disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0012 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Application Site Rash	General disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Asthenia	General disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Chest Pain	General disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Feeling Abnormal	General disorders	MedDRA (12.0)	Systematic Assessment		EG0002 events1 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Generalised Oedema	General disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Influenza Like Illness	General disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Thirst	General disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Vessel Puncture Site Pain	General disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Catheter Related Complication	General disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Infusion Site Pain	General disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Oedema Peripheral	General disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Pain	General disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Cystic Fibrosis Related Diabetes	Congenital, familial and genetic disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0013 events3 affected112 at risk EG0020 events0 affected5 at risk EG003
Rash Papular	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0013 events3 affected112 at risk EG0020 events0 affected5 at risk EG003
Rash Vesicular	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0013 events2 affected112 at risk EG0020 events0 affected5 at risk EG003
Blister	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Night Sweats	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Photodermatosis	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Photosensitivity Reaction	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Rash Macular	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0012 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Urticaria	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Red Man Syndrome	Skin and subcutaneous tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0021 events1 affected5 at risk EG003
Sinus Headache	Nervous system disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0012 events2 affected112 at risk EG0020 events0 affected5 at risk EG003
Burning Sensation	Nervous system disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Hyperaesthesia	Nervous system disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Migraine	Nervous system disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Presyncope	Nervous system disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Somnolence	Nervous system disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Syncope	Nervous system disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0015 events3 affected112 at risk EG0020 events0 affected5 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0002 events1 affected28 at risk EG0012 events2 affected112 at risk EG0020 events0 affected5 at risk EG003
Pain In Extremity	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0013 events3 affected112 at risk EG0020 events0 affected5 at risk EG003
Joint Swelling	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0012 events2 affected112 at risk EG0020 events0 affected5 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0012 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Bone Pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Clubbing	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Muscular Weakness	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Myopathy	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Neck Pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Arthropathy	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Synovial Cyst	Musculoskeletal and connective tissue disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0013 events2 affected112 at risk EG0020 events0 affected5 at risk EG003
Skin Laceration	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0012 events2 affected112 at risk EG0020 events0 affected5 at risk EG003
Foreign Body Trauma	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Joint Injury	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Joint Sprain	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Muscle Strain	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Procedural Pain	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Procedural Site Reaction	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Thermal Burn	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Traumatic Brain Injury	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Animal Bite	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Arthropod Sting	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0021 events1 affected5 at risk EG003
Excoriation	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Head Injury	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Road Traffic Accident	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Sunburn	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0021 events1 affected5 at risk EG003
Conjunctivitis	Eye disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0013 events3 affected112 at risk EG0020 events0 affected5 at risk EG003
Lacrimation Increased	Eye disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Conjunctivitis Allergic	Eye disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Eye Pruritus	Eye disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Eyelid Oedema	Eye disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Visual Impairment	Eye disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Erythema Of Eyelid	Eye disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0012 events2 affected112 at risk EG0020 events0 affected5 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0013 events3 affected112 at risk EG0020 events0 affected5 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Vitamin D Deficiency	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0021 events1 affected5 at risk EG003
Glucose Tolerance Impaired	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Hypovitaminosis	Metabolism and nutrition disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0013 events3 affected112 at risk EG0020 events0 affected5 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0013 events3 affected112 at risk EG0020 events0 affected5 at risk EG003
Abnormal Dreams	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Depression	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Hallucination	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Insomnia	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Adjustment Disorder	Psychiatric disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Calculus Bladder	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Chromaturia	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Proteinuria	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Renal Cyst	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Renal Failure Acute	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Urinary Retention	Renal and urinary disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Breast Tenderness	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Dysmenorrhoea	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Prostatic Cyst	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Testicular Pain	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Testicular Swelling	Reproductive system and breast disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Middle Ear Effusion	Ear and labyrinth disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Tinnitus	Ear and labyrinth disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Hepatosplenomegaly	Hepatobiliary disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Allergy to Animal	Immune system disorders	MedDRA (12.0)	Systematic Assessment		EG0001 events1 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
Seasonal Allergy	Immune system disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0021 events1 affected5 at risk EG003
Supraventricular Extrasystoles	Cardiac disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Focal Nodular Hyperplasia	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Skin Papilloma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0010 events0 affected112 at risk EG0020 events0 affected5 at risk EG003
wisdom teeth removal	Surgical and medical procedures	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003
Hypotension	Vascular disorders	MedDRA (12.0)	Systematic Assessment		EG0000 events0 affected28 at risk EG0011 events1 affected112 at risk EG0020 events0 affected5 at risk EG003

ID	Term
D003550	Cystic Fibrosis
D005355	Fibrosis
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D030342	Genetic Diseases, Inborn
D007232	Infant, Newborn, Diseases
D010335	Pathologic Processes

ID	Term
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description
BG000	Placebo - Part A	Placebo matched to ivacaftor tablet orally every 12 hours (q12h) for 16 weeks during Part A (double-blind treatment period).
BG001	Ivacaftor - Part A	Ivacaftor 150 milligram (mg) tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
BG002	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo - Part A	Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).	6	28	25	28
EG001	Ivacaftor - Part A	Ivacaftor 150 milligram (mg) tablet orally q12h for 16 weeks during Part A (double-blind treatment period).	15	112	98	112
EG002	Placebo/Ivacaftor - Part B	Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).	2	5	5	5
EG003	Ivacaftor/Ivacaftor - Part B	Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).	14	33	30	33