Study of VX-809 Alone and in Combination With VX-770 in C... | NCT01225211 | Trialant
NCT01225211
Sponsor
Vertex Pharmaceuticals Incorporated
Status
Completed
Last Update Posted
Oct 5, 2015Estimated
Enrollment
312Actual
Phase
Phase 2
Conditions
Cystic Fibrosis
Interventions
Lumacaftor
Ivacaftor
Lumacaftor Placebo
Ivacaftor Placebo
Countries
United States
Australia
Belgium
France
Germany
New Zealand
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01225211
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
VX09-809-102
Secondary IDs
ID
Type
Description
Link
2010-020413-90
EudraCT Number
Brief Title
Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation
Official Title
A Phase 2, Multicenter, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation
Acronym
Not provided
Organization
Vertex Pharmaceuticals IncorporatedINDUSTRY
Status Module
Record Verification Date
Sep 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 2010
Primary Completion Date
Apr 2014Actual
Completion Date
Apr 2014Actual
First Submitted Date
Oct 15, 2010
First Submission Date that Met QC Criteria
Oct 19, 2010
First Posted Date
Oct 20, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 1, 2015
Results First Submitted that Met QC Criteria
Sep 2, 2015
Results First Posted Date
Oct 5, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
May 8, 2015
Certification/Extension First Submitted that Passed QC Review
May 8, 2015
Certification/Extension First Posted Date
Jun 2, 2015Estimated
Last Update Submitted Date
Sep 2, 2015
Last Update Posted Date
Oct 5, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Vertex Pharmaceuticals IncorporatedINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to evaluate of the safety, efficacy, pharmacokinetics (PK) and pharmacodynamic (PD) effects of lumacaftor (VX-809) alone and when coadministered with ivacaftor (VX-770) in participants with cystic fibrosis, homozygous or heterozygous for the F508del-CFTR mutation.
Detailed Description
Not provided
Conditions Module
Conditions
Cystic Fibrosis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
312Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Cohort 1: Placebo
Placebo Comparator
Participants homozygous (HO) for the F508del-CF transmembrane conductance regulator gene (CFTR) mutation received lumacaftor matched placebo once daily (qd) (Day 1 through Day 14), followed by lumacaftor matched placebo qd in combination with ivacaftor matched placebo every 12 hours (q12h) (Day 15 through Day 21).
Participants homozygous for the F508del-CFTR mutation received 200 milligram (mg) of lumacaftor (LUM) qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor (IVA) q12h (Day 15 through Day 21).
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
Drug: Lumacaftor
Drug: Ivacaftor
Cohort 2 and 3: Placebo (HO and HE)
Placebo Comparator
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
Cohort 1: Safety and Tolerability Based on Adverse Events (AEs)
AE: any untoward medical occurrence in a participant during study; irrespective of relationship with treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent. AE includes serious AEs (SAEs) as well as Non-SAEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Number of participants with AEs and SAEs are reported. AE that started at/after initial dosing of study drug, or increased in severity after initial dosing of study drug is considered treatment-emergent. Results are reported separately for monotherapy period (Period 1: Day 1 to Day 14) and combination therapy period (Period 2: Day 15 to Day 21).
Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21)
Cohort 2 and 3: Safety and Tolerability Based on Adverse Events (AEs)
Detailed description is provided in Outcome Measure 1. Results are reported separately for monotherapy period (Period 1: Day 1 to Day 28) and combination therapy period (Period 2: Day 29 to Day 56).
Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56)
Cohort 4: Safety and Tolerability Assessed by Number of Participants With AEs and SAEs
AEs and SAEs are defined in Outcome Measure 1.
Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
Cohort 1: Absolute Change From Day 14 in Sweat Chloride at Day 21
Cohort 1: Day 14, Day 21
Cohort 2 And 3: Absolute Change From Day 28 in Sweat Chloride at Day 56
Secondary Outcomes
Measure
Description
Time Frame
Cohort 1: Absolute Change From Baseline in Sweat Chloride at Day 14
Cohort 1: Baseline, Day 14
Cohort 2 And 3: Absolute Change From Baseline in Sweat Chloride at Day 14
Cohort 2: Baseline, Day 14
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Male or female participants with confirmed diagnosis of CF
Must have the F508del-CFTR mutation on at least 1 allele.
FEV1 greater than equal (>=) 40% of predicted normal for age, gender, and height (Knudson standards)(Cohort 1, 2, and 3); FEV1 40-90% of predicted normal for age, gender, and height (Hankinson standards (Cohort 4)
Participant of child-bearing potential and who are sexually active must meet the contraception requirements
Exclusion Criteria:
History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the participant (e.g., cirrhosis with portal hypertension).
An acute illness including acute upper or lower respiratory infection, pulmonary exacerbation or changes in therapy (including antibiotics) for pulmonary disease within 14 days (Cohort 1, 2, and 3) or 28 days (Cohort 4) before receiving the first dose of study drug.
History of solid organ or hematological transplantation.
History of alcohol abuse or drug addiction in the past year, including cannabis, cocaine, and opiates.
Ongoing participation in another therapeutic clinical study, or prior participation in an investigational drug study without appropriate washout
Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of non-hormonal contraception
Participants enrolled in Cohort 1 or Cohort 2 will not be eligible for Cohort 3
Ongoing or prior participation in an investigational drug study within 30 days of the Screening Visit
Heterozygous participants who participated in Cohort 2 and meet the eligibility criteria for Cohort 4 may participate in Cohort 4
Evidence of lens opacity or cataract as determined by the ophthalmologic examination (Cohort 4 only)
Heneghan M, Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2023 Nov 20;11(11):CD010966. doi: 10.1002/14651858.CD010966.pub4.
Study included 4 cohorts which were studied in sequential manner. For results reporting, combined placebo arm was reported for Cohort 2 and 3 and results for these 2 cohorts are reported collectively.
Recruitment Details
Participants in each cohort are mutually exclusive. A total of 312 participants were randomized of which one participant did not receive any treatment and a total of 311 participants were treated.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Cohort 1: Placebo
Participants homozygous (HO) for the F508del-CF transmembrane conductance regulator gene (CFTR) mutation received lumacaftor matched placebo once daily (qd) (Day 1 through Day 14), followed by lumacaftor matched placebo qd in combination with ivacaftor matched placebo every 12 hours (q12h) (Day 15 through Day 21).
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Drug: Lumacaftor
Drug: Ivacaftor
Cohort 4: Placebo
Placebo Comparator
Participants heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
Drug: Lumacaftor Placebo
Drug: Ivacaftor Placebo
Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
Experimental
Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
Cohort 4: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 56
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 Hankinson method.
Cohort 4: Baseline, Day 56
Cohort 4: Absolute Change From Baseline in Sweat Chloride at Day 56
Cohort 4: Baseline, Day 56
Cohort 1: Absolute Change From Day 14 in FEV1 at Day 21
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Cohort 1: Day 14, Day 21
Cohort 1: Absolute Change From Day 14 in ppFEV1 at Day 21
FEV1 and ppFEV1 are defined in Outcome Measure 6.
Cohort 1: Day 14, Day 21
Cohort 2 and 3: Absolute Change From Day 28 in ppFEV1 at Day 56
FEV1 and ppFEV1 are defined in Outcome Measure 6.
Cohort 2 and 3: Day 28, Day 56
Cohort 2 and 3: Relative Change From Day 28 in ppFEV1 at Day 56
FEV1 and ppFEV1 are defined in Outcome Measure 6.
Cohort 2 and 3: Day 28, Day 56
Cohort 2 and 3: Absolute Change From Baseline in ppFEV1 at Day 28 and 56
FEV1 and ppFEV1 are defined in Outcome Measure 6.
Cohort 2 and 3: Baseline, Day 28 and 56
Cohort 2 and 3: Relative Change From Baseline in FEV1 at Day 28 and 56
FEV1 and ppFEV1 are defined in Outcome Measure 6.
Cohort 2 and 3: Baseline, Day 28 and 56
Cohort 4: Relative Change From Baseline in Percent Predicted FEV1 at Day 56
FEV1 and ppFEV1 are defined in Outcome Measure 6.
Cohort 4: Baseline, Day 56
Cohort 2 and 3: Absolute Change From Day 28 in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Day 56
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for subjects 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.
Cohort 2 and 3: Day 28, Day 56
Cohort 4: Absolute Change From Baseline in CFQ-R Respiratory Domain Score at Day 56
CFQ-R respiratory domain is defined in Outcome Measure 17.
Cohort 4: Baseline, Day 56
Cohort 4: Absolute Change From Baseline in Body Mass Index (BMI) at Day 56
BMI was defined as weight in kilogram (kg) divided by height*height in square meter (m^2).
Cohort 4: Baseline, Day 56
Cohort 4: Absolute Change From Baseline in Weight at Day 56
Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD010966. doi: 10.1002/14651858.CD010966.pub3.
Rowe SM, McColley SA, Rietschel E, Li X, Bell SC, Konstan MW, Marigowda G, Waltz D, Boyle MP; VX09-809-102 Study Group. Lumacaftor/Ivacaftor Treatment of Patients with Cystic Fibrosis Heterozygous for F508del-CFTR. Ann Am Thorac Soc. 2017 Feb;14(2):213-219. doi: 10.1513/AnnalsATS.201609-689OC.
Boyle MP, Bell SC, Konstan MW, McColley SA, Rowe SM, Rietschel E, Huang X, Waltz D, Patel NR, Rodman D; VX09-809-102 study group. A CFTR corrector (lumacaftor) and a CFTR potentiator (ivacaftor) for treatment of patients with cystic fibrosis who have a phe508del CFTR mutation: a phase 2 randomised controlled trial. Lancet Respir Med. 2014 Jul;2(7):527-38. doi: 10.1016/S2213-2600(14)70132-8. Epub 2014 Jun 24.
Participants homozygous for the F508del-CFTR mutation received 200 milligram (mg) of lumacaftor (LUM) qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor (IVA) q12h (Day 15 through Day 21).
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
FG003
Cohort 2 and 3: Placebo (HO and HE)
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
FG008
Cohort 4: Placebo
Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
FG009
Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
FG00021 subjects
FG00120 subjects
FG00221 subjects
FG00327 subjects
FG00423 subjects
FG00521 subjects
FG00642 subjects
FG00711 subjects
FG00863 subjects
FG00962 subjects
COMPLETED
FG00021 subjects
FG00120 subjects
FG00220 subjects
FG00327 subjects
FG00423 subjects
FG00521 subjects
FG00641 subjects
FG00711 subjects
FG00862 subjects
FG00957 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0081 subjects
FG0095 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Full Analysis Set (FAS) for Cohort 1, 2, and 3 included all randomized participants who received at least 1 dose of study drug and FAS for Cohort 4 included all randomized participants who received any amount of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Cohort 1: Placebo
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14), followed by lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
BG003
Cohort 2 and 3: Placebo (HO and HE)
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
BG008
Cohort 4: Placebo
Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
BG009
Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
BG010
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00021
BG00120
BG00221
BG00327
BG00423
BG00521
BG00642
BG00711
BG00863
BG00962
BG010311
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00010
BG0018
BG002
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
Cohort 1: Safety and Tolerability Based on Adverse Events (AEs)
AE: any untoward medical occurrence in a participant during study; irrespective of relationship with treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after informed consent. AE includes serious AEs (SAEs) as well as Non-SAEs. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Number of participants with AEs and SAEs are reported. AE that started at/after initial dosing of study drug, or increased in severity after initial dosing of study drug is considered treatment-emergent. Results are reported separately for monotherapy period (Period 1: Day 1 to Day 14) and combination therapy period (Period 2: Day 15 to Day 21).
Cohort 1 Safety Set included all participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.
Posted
Number
participants
Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21)
ID
Title
Description
OG000
Cohort 1: Placebo - Period 1
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
OG001
Cohort 1: LUM 200 mg qd - Period 1
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
OG002
Cohort 1: Placebo - Period 2
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
Units
Counts
Participants
OG00021
OG00141
OG00221
OG003
Title
Denominators
Categories
Participants with any AEs
Title
Measurements
OG00012
OG00129
OG00215
OG003
Primary
Cohort 2 and 3: Safety and Tolerability Based on Adverse Events (AEs)
Detailed description is provided in Outcome Measure 1. Results are reported separately for monotherapy period (Period 1: Day 1 to Day 28) and combination therapy period (Period 2: Day 29 to Day 56).
Cohort 2 and 3 Safety Set included all participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.
Posted
Number
participants
Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56)
ID
Title
Description
OG000
Cohort 2 and 3: Placebo (HO and HE) - Period 1
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28).
OG001
Cohort 2: LUM 200 mg qd - Period 1
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28).
OG002
Cohort 2: LUM 400 mg qd - Period 1
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28).
OG003
Primary
Cohort 4: Safety and Tolerability Assessed by Number of Participants With AEs and SAEs
AEs and SAEs are defined in Outcome Measure 1.
Cohort 4 Safety Set included all participants who received at least 1 dose of study drug in Cohort 4.
Posted
Number
participants
Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
ID
Title
Description
OG000
Cohort 4: Placebo
Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
OG001
Cohort 4: Active Study Drug
Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
Units
Counts
Participants
OG000
Primary
Cohort 1: Absolute Change From Day 14 in Sweat Chloride at Day 21
Cohort 1 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
OG002
Cohort 1: Placebo - Period 2
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
Primary
Cohort 2 And 3: Absolute Change From Day 28 in Sweat Chloride at Day 56
Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Cohort 4: Absolute Change From Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (ppFEV1) at Day 56
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 Hankinson method.
Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.
Posted
Least Squares Mean
Standard Error
percent predicted of FEV1
Cohort 4: Baseline, Day 56
ID
Title
Description
OG000
Cohort 4: Placebo
Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
OG001
Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
Units
Counts
Participants
Secondary
Cohort 1: Absolute Change From Baseline in Sweat Chloride at Day 14
Cohort 1 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.
Posted
Least Squares Mean
95% Confidence Interval
mmol/L
Cohort 1: Baseline, Day 14
ID
Title
Description
OG000
Cohort 1: LUM 200 mg qd - Period 1
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
OG001
Cohort 1: Placebo - Period 1
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
Units
Counts
Participants
OG000
Secondary
Cohort 2 And 3: Absolute Change From Baseline in Sweat Chloride at Day 14
Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.
Posted
Least Squares Mean
95% Confidence Interval
mmol/L
Cohort 2: Baseline, Day 14
ID
Title
Description
OG000
Cohort 2: LUM 200 mg qd - Period 1
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28).
OG001
Cohort 2: LUM 400 mg qd - Period 1
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28).
OG002
Cohort 2: LUM 600 mg qd (HO) - Period 1
Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).
OG003
Cohort 2: LUM 600 mg qd (HE) - Period 1
Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).
Secondary
Cohort 4: Absolute Change From Baseline in Sweat Chloride at Day 56
Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.
Posted
Least Squares Mean
Standard Error
mmol/L
Cohort 4: Baseline, Day 56
ID
Title
Description
OG000
Cohort 4: Placebo
Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
OG001
Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
Units
Counts
Participants
OG000
Secondary
Cohort 1: Absolute Change From Day 14 in FEV1 at Day 21
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Cohort 1 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
OG002
Cohort 1: Placebo - Period 2
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
Secondary
Cohort 1: Absolute Change From Day 14 in ppFEV1 at Day 21
FEV1 and ppFEV1 are defined in Outcome Measure 6.
Cohort 1 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 1. Number of participants analysed signifies participants evaluable for this outcome.
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
OG002
Cohort 1: Placebo - Period 2
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
Secondary
Cohort 2 and 3: Absolute Change From Day 28 in ppFEV1 at Day 56
FEV1 and ppFEV1 are defined in Outcome Measure 6.
Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Secondary
Cohort 2 and 3: Relative Change From Day 28 in ppFEV1 at Day 56
FEV1 and ppFEV1 are defined in Outcome Measure 6.
Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Secondary
Cohort 2 and 3: Absolute Change From Baseline in ppFEV1 at Day 28 and 56
FEV1 and ppFEV1 are defined in Outcome Measure 6.
Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Here, n = participants evaluable for specified category for each arm, respectively. Number of participants analysed signifies participants evaluable for this outcome.
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Cohort 2 and 3: Relative Change From Baseline in FEV1 at Day 28 and 56
FEV1 and ppFEV1 are defined in Outcome Measure 6.
Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Here, n = participants evaluable for specified category for each arm, respectively. Number of participants analysed signifies participants evaluable for this outcome.
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Cohort 4: Relative Change From Baseline in Percent Predicted FEV1 at Day 56
FEV1 and ppFEV1 are defined in Outcome Measure 6.
Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.
Posted
Least Squares Mean
Standard Error
percent change
Cohort 4: Baseline, Day 56
ID
Title
Description
OG000
Cohort 4: Placebo
Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
OG001
Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
Units
Counts
Participants
OG000
Secondary
Cohort 2 and 3: Absolute Change From Day 28 in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score at Day 56
The CFQ-R is a validated participant-reported outcome measuring health-related quality of life for subjects 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.
Cohort 2 and 3 Full Analysis Set included all randomized participants who received at least 1 dose of study drug in Cohort 2 or 3. Number of participants analysed signifies participants evaluable for this outcome.
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Cohort 4: Absolute Change From Baseline in CFQ-R Respiratory Domain Score at Day 56
CFQ-R respiratory domain is defined in Outcome Measure 17.
Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.
Posted
Least Squares Mean
Standard Error
units on a scale
Cohort 4: Baseline, Day 56
ID
Title
Description
OG000
Cohort 4: Placebo
Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
OG001
Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
Units
Counts
Participants
OG000
Secondary
Cohort 4: Absolute Change From Baseline in Body Mass Index (BMI) at Day 56
BMI was defined as weight in kilogram (kg) divided by height*height in square meter (m^2).
Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.
Posted
Least Squares Mean
Standard Error
kg/m^2
Cohort 4: Baseline, Day 56
ID
Title
Description
OG000
Cohort 4: Placebo
Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
OG001
Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
Units
Counts
Participants
OG000
Secondary
Cohort 4: Absolute Change From Baseline in Weight at Day 56
Cohort 4 Full Analysis Set included all randomized participants who received any amount of study drug in Cohort 4. Number of participants analysed signifies participants evaluable for this outcome.
Posted
Least Squares Mean
Standard Error
kg
Cohort 4: Baseline, Day 56
ID
Title
Description
OG000
Cohort 4: Placebo
Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
OG001
Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
Units
Counts
Participants
OG000
Time Frame
Cohort 1: Day 1 up to 28 days after last dose (Last dose = Day 21); Cohort 2 and 3: Day 1 up to 28 days after last dose (Last dose = Day 56); Cohort 4: Day 1 up to 28 days after last dose (Last dose = Day 56)
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Cohort 1: LUM 200 mg qd - Period 1
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
0
20
12
20
EG003
Cohort 1: Placebo - Period 1
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
0
21
12
21
EG004
Cohort 1: Placebo - Period 2
Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
0
21
15
21
EG005
Cohort 2: LUM 200 mg qd - Period 1
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28).
2
23
17
23
EG006
Cohort 2: LUM 400 mg qd - Period 1
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28).
0
21
18
21
EG007
Cohort 2: LUM 600 mg qd - Period 1
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).
3
42
37
42
EG008
Cohort 3: LUM 400 mg q12h - Period 1
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28).
2
11
6
11
EG009
Cohort 2 and 3: Placebo (HO and HE) - Period 1
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28).
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
1
11
10
11
EG014
Cohort 2 and 3: Placebo (HO and HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
4
27
20
27
EG015
Cohort 4: Placebo
Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
5
63
53
63
EG016
Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h
Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
9
62
51
62
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Infective pulmonary exacerbation of cystic fibrosis
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG0030 events0 affected21 at risk
EG004
Haemoptysis
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Spirometry abnormal
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
CYSTIC FIBROSIS LUNG
Congenital, familial and genetic disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
RESPIRATION ABNORMAL
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
HYPERSENSITIVITY
Immune system disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
PNEUMONIA
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
BLOOD CREATINE PHOSPHOKINASE INCREASED
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0006 events6 affected41 at risk
EG0015 events4 affected20 at risk
EG0021 events1 affected20 at risk
EG0031 events1 affected21 at risk
EG0044 events4 affected21 at risk
EG0053 events3 affected23 at risk
EG0068 events8 affected21 at risk
EG00713 events12 affected42 at risk
EG0081 events1 affected11 at risk
EG0096 events6 affected27 at risk
EG0105 events3 affected21 at risk
EG0115 events5 affected20 at risk
EG0126 events5 affected38 at risk
EG0134 events3 affected11 at risk
EG0146 events6 affected27 at risk
EG01515 events12 affected63 at risk
EG01616 events13 affected62 at risk
PRODUCTIVE COUGH
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0003 events3 affected41 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
OROPHARYNGEAL PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0002 events2 affected41 at risk
EG0011 events1 affected20 at risk
EG0022 events2 affected20 at risk
EG003
NASAL CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0011 events1 affected20 at risk
EG0023 events3 affected20 at risk
EG003
RHINORRHOEA
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0002 events2 affected41 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected20 at risk
EG003
DYSPNOEA
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0003 events3 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
RALES
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
RESPIRATION ABNORMAL
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
WHEEZING
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
LUNG HYPERINFLATION
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
RESPIRATORY TRACT CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected20 at risk
EG003
BRONCHIAL SECRETION RETENTION
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
HYPOVENTILATION
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
INCREASED VISCOSITY OF BRONCHIAL SECRETION
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
NASAL MUCOSAL DISORDER
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
NASAL OEDEMA
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
OBSTRUCTIVE AIRWAYS DISORDER
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
PROLONGED EXPIRATION
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
RHINITIS ALLERGIC
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
RHONCHI
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
SINUS CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
SINUS DISORDER
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
SNEEZING
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
HAEMOPTYSIS
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
PLEURITIC PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
EPISTAXIS
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
PARANASAL SINUS HYPERSECRETION
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
SPUTUM DISCOLOURED
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
OBSTRUCTIVE AIRWAYS DISORDER
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
BRONCHOSPASM
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
DYSPHONIA
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
DYSPNOEA EXERTIONAL
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
NASAL INFLAMMATION
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
PAINFUL RESPIRATION
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
PULMONARY CONGESTION
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
SPUTUM INCREASED
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
UPPER-AIRWAY COUGH SYNDROME
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
BRONCHIAL OBSTRUCTION
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
HICCUPS
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
NASAL DRYNESS
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
PHARYNGEAL OEDEMA
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
PLEURISY
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
PULMONARY PAIN
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
DIZZINESS
Nervous system disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0012 events2 affected20 at risk
EG0021 events1 affected20 at risk
EG003
SINUS HEADACHE
Nervous system disorders
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
MIGRAINE
Nervous system disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
TREMOR
Nervous system disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
TUNNEL VISION
Nervous system disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
HEADACHE
Nervous system disorders
MedDRA (12.0)
Systematic Assessment
EG0004 events4 affected41 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
NEURALGIA
Nervous system disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
PRESYNCOPE
Nervous system disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
LETHARGY
Nervous system disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
DIARRHOEA
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected20 at risk
EG003
ABDOMINAL PAIN UPPER
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0003 events3 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
ABDOMINAL DISCOMFORT
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
ABDOMINAL PAIN
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0002 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
NAUSEA
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0002 events2 affected41 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
VOMITING
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
ABDOMINAL DISTENSION
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
ABDOMINAL PAIN LOWER
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
FLATULENCE
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
GASTROOESOPHAGEAL REFLUX DISEASE
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
HYPOAESTHESIA ORAL
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
CONSTIPATION
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
DISTAL ILEAL OBSTRUCTION SYNDROME
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
DRY MOUTH
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
DYSPEPSIA
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
RECTAL HAEMORRHAGE
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
TOOTHACHE
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
FREQUENT BOWEL MOVEMENTS
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
FAECAL VOLUME INCREASED
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
DYSPHAGIA
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
LIP SWELLING
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
POST-TUSSIVE VOMITING
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
STEATORRHOEA
Gastrointestinal disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
FATIGUE
General disorders
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
PYREXIA
General disorders
MedDRA (12.0)
Systematic Assessment
EG0003 events3 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
PAIN
General disorders
MedDRA (12.0)
Systematic Assessment
EG0003 events3 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
APPLICATION SITE PRURITUS
General disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
CATHETER SITE HAEMORRHAGE
General disorders
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
CATHETER SITE PAIN
General disorders
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
CHEST DISCOMFORT
General disorders
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
CHILLS
General disorders
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
FEELING HOT
General disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
INJECTION SITE HAEMORRHAGE
General disorders
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
BLOOD GLUCOSE INCREASED
Investigations
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
C-REACTIVE PROTEIN INCREASED
Investigations
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
GLUCOSE URINE PRESENT
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected20 at risk
EG003
LIVER FUNCTION TEST ABNORMAL
Investigations
MedDRA (12.0)
Systematic Assessment
EG0002 events2 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
PROTHROMBIN TIME PROLONGED
Investigations
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected20 at risk
EG003
PULMONARY FUNCTION TEST DECREASED
Investigations
MedDRA (12.0)
Systematic Assessment
EG0002 events2 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
ALANINE AMINOTRANSFERASE INCREASED
Investigations
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
BLOOD IMMUNOGLOBULIN E INCREASED
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
BLOOD SODIUM DECREASED
Investigations
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
BLOOD URINE PRESENT
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
HEPATIC ENZYME INCREASED
Investigations
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
INTERNATIONAL NORMALISED RATIO INCREASED
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
VIRAL INFECTION
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
RHINITIS
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0012 events2 affected20 at risk
EG0020 events0 affected20 at risk
EG003
BACTERIAL DISEASE CARRIER
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0012 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
CANDIDIASIS
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
GASTROENTERITIS
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
ORAL HERPES
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
VIRAL UPPER RESPIRATORY TRACT INFECTION
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
ARTHRALGIA
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
MUSCULOSKELETAL CHEST PAIN
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0011 events1 affected20 at risk
EG0021 events1 affected20 at risk
EG003
PAIN IN EXTREMITY
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
MUSCLE SPASMS
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
MYALGIA
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
RASH MACULAR
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0003 events2 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
RASH PAPULAR
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
ACNE
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
DERMATITIS CONTACT
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
HYPERHIDROSIS
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
HYPOAESTHESIA FACIAL
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
NIGHT SWEATS
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
PRURITUS
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
RASH FOLLICULAR
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
RASH MACULO-PAPULAR
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
URTICARIA
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
HYPOGLYCAEMIA
Metabolism and nutrition disorders
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
DEHYDRATION
Metabolism and nutrition disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
CYSTIC FIBROSIS LUNG
Congenital, familial and genetic disorders
MedDRA (12.0)
Systematic Assessment
EG0002 events2 affected41 at risk
EG0012 events2 affected20 at risk
EG0021 events1 affected20 at risk
EG003
CHEST INJURY
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
EXCORIATION
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
JOINT SPRAIN
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
LIMB INJURY
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
MUSCLE STRAIN
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
THERMAL BURN
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
ANXIETY
Psychiatric disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
INSOMNIA
Psychiatric disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected20 at risk
EG003
MOOD SWINGS
Psychiatric disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
DYSMENORRHOEA
Reproductive system and breast disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
MENSTRUATION DELAYED
Reproductive system and breast disorders
MedDRA (12.0)
Systematic Assessment
EG0001 events1 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
LYMPHADENOPATHY
Blood and lymphatic system disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
SINUS BRADYCARDIA
Cardiac disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected20 at risk
EG003
EYELID OEDEMA
Eye disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
PYURIA
Renal and urinary disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Infective pulmonary exacerbation of cystic fibrosis
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
NASOPHARYNGITIS
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
ORAL CANDIDIASIS
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
PHARYNGITIS STREPTOCOCCAL
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Rash pustular
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Acute sinusitis
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Bronchitis
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Bronchopulmonary aspergillosis allergic
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
INFLUENZA
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Kidney infection
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Lower respiratory tract infection bacterial
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Lung infection
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Upper respiratory tract infection bacterial
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
SINUSITIS
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
FUNGAL INFECTION
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
HERPES SIMPLEX
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
LARYNGITIS
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
OTITIS MEDIA
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
PHARYNGITIS
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
RHINOVIRUS INFECTION
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Forced expiratory volume decreased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Sputum abnormal
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Blood creatinine decreased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Blood creatinine increased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Blood immunoglobulin G increased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Blood lactate dehydrogenase increased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Chest X-ray abnormal
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Eosinophil count increased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Interleukin level increased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Protein total increased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Transaminases increased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Weight decreased
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
WHITE BLOOD CELL COUNT INCREASED
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
BLOOD GLUCOSE DECREASED
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
NEUTROPHIL COUNT INCREASED
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
BACTERIA URINE IDENTIFIED
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
BLOOD PHOSPHORUS DECREASED
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
BLOOD POTASSIUM INCREASED
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
CULTURE THROAT POSITIVE
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
ELECTROCARDIOGRAM QT PROLONGED
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
FUNGUS SPUTUM TEST POSITIVE
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
PLATELET COUNT DECREASED
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
PROTEIN URINE PRESENT
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
URINE KETONE BODY PRESENT
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
WHITE BLOOD CELLS URINE POSITIVE
Investigations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Chest pain
General disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Exercise tolerance decreased
General disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Malaise
General disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Vessel puncture site bruise
General disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
NON-CARDIAC CHEST PAIN
General disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
APPLICATION SITE IRRITATION
General disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
FEELING OF BODY TEMPERATURE CHANGE
General disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
INFLUENZA LIKE ILLNESS
General disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
DYSGEUSIA
Nervous system disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Dermatitis atopic
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Rash generalised
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
RASH
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
ALOPECIA
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
ECCHYMOSIS
Skin and subcutaneous tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Clubbing
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Osteopenia
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
MUSCULOSKELETAL DISCOMFORT
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
COSTOCHONDRITIS
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
MEDIAL TIBIAL STRESS SYNDROME
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
MUSCLE TIGHTNESS
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
MUSCULOSKELETAL STIFFNESS
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
NECK PAIN
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
TORTICOLLIS
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Procedural pain
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
JOINT INJURY
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
SUNBURN
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
VERTEBRAL INJURY
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
EAR PAIN
Ear and labyrinth disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
EAR DISCOMFORT
Ear and labyrinth disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
EAR DISORDER
Ear and labyrinth disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
TINNITUS
Ear and labyrinth disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
DEPRESSED MOOD
Psychiatric disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Abnormal dreams
Psychiatric disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
ANOREXIA
Metabolism and nutrition disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
HYPERCALCAEMIA
Metabolism and nutrition disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
HYPERGLYCAEMIA
Metabolism and nutrition disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
BREAST TENDERNESS
Reproductive system and breast disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
MENOMETRORRHAGIA
Reproductive system and breast disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
MENORRHAGIA
Reproductive system and breast disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
MENSTRUAL DISORDER
Reproductive system and breast disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Dysmenorrhoea
Reproductive system and breast disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Vulvovaginal burning sensation
Reproductive system and breast disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Vulvovaginal discomfort
Reproductive system and breast disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Eosinophilia
Blood and lymphatic system disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Increased tendency to bruise
Blood and lymphatic system disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Leukopenia
Blood and lymphatic system disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Cystic fibrosis related diabetes
Congenital, familial and genetic disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Chromaturia
Renal and urinary disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Hot flush
Vascular disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
DYSURIA
Renal and urinary disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
PROTEINURIA
Renal and urinary disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
ARTHROPOD BITE
Injury, poisoning and procedural complications
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
CONJUNCTIVITIS
Eye disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Vision Blurred
Eye disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
VIRAL RASH
Infections and infestations
MedDRA (12.0)
Systematic Assessment
EG0000 events0 affected41 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected20 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
PI is free to publish results of the study after (1) the first multi-center publication, (2) if the sponsor elects not to publish the results, or (3) 18 months after close of the study, whichever occurs first. Proposed publications are to be submitted to the sponsor for review and comment for a period of at least 45 days (which may be extended under certain circumstances related to protection of intellectual property); the sponsor cannot require changes to the proposed publications.
Point of Contact
Title
Organization
Phone
Extension
Email
Medical Monitor
Vertex Pharmaceuticals Incorporated
617-341-6777
medicalinfo@vrtx.com
ID
Term
D003550
Cystic Fibrosis
Ancestor Terms
ID
Term
D010182
Pancreatic Diseases
D004066
Digestive System Diseases
D008171
Lung Diseases
D012140
Respiratory Tract Diseases
D030342
Genetic Diseases, Inborn
D009358
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D007232
Infant, Newborn, Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C569105
lumacaftor
C545203
ivacaftor
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0081 subjects
FG0093 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0091 subjects
0
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
Between 18 and 65 years
BG00021
BG00120
BG00221
BG00327
BG00423
BG00521
BG00642
BG00711
BG00863
BG00962
BG010311
>=65 years
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
13
BG0039
BG00411
BG0059
BG00619
BG0075
BG00831
BG00929
BG010144
Male
BG00011
BG00112
BG0028
BG00318
BG00412
BG00512
BG00623
BG0076
BG00832
BG00933
BG010167
20
OG00420
14
OG00412
Participants with SAEs
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
Cohort 2: LUM 600 mg qd - Period 1
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).
OG004
Cohort 3: LUM 400 mg q12h - Period 1
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28).
OG005
Cohort 2 and 3: Placebo (HO and HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Units
Counts
Participants
OG00027
OG00123
OG00221
OG00342
OG00411
OG00527
OG00621
OG00720
OG00838
OG00911
Title
Denominators
Categories
Participants with any AEs
Title
Measurements
OG00023
OG00118
OG00218
OG00337
OG0047
OG00520
OG00612
OG00715
OG00826
OG00910
Participants with SAEs
Title
Measurements
OG0001
OG0012
OG0020
OG003
63
OG00162
Title
Denominators
Categories
Participants with any AEs
Title
Measurements
OG00053
OG00152
Participants with SAEs
Title
Measurements
OG0005
OG0019
Units
Counts
Participants
OG00019
OG00114
OG00217
Title
Denominators
Categories
Title
Measurements
OG000-2.131(-5.381 to 1.119)
OG001-9.128(-12.893 to -5.362)
OG0020.548(-2.955 to 4.052)
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
OG002
ANCOVA
0.267
LS Mean difference
-2.679
2-Sided
95
-7.484
2.125
No
Superiority or Other
OG001
OG002
ANCOVA
<0.001
LS Mean difference
-9.676
2-Sided
95
-14.801
-4.551
No
Superiority or Other
Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
OG005
Cohort 2 and 3: Placebo (HO and HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
Units
Counts
Participants
OG00021
OG00119
OG00220
OG00317
OG0049
OG00524
Title
Denominators
Categories
Title
Measurements
OG0000.321(-4.208 to 4.849)
OG001-1.043(-5.800 to 3.714)
OG002-2.900(-7.542 to 1.743)
OG003-1.240(-6.287 to 3.807)
OG004-2.154(-9.177 to 4.870)
OG0051.627(-2.661 to 5.915)
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
OG005
ANCOVA
0.680
LS Mean difference
-1.306
2-Sided
95
-7.565
4.953
No
Superiority or Other
OG001
OG005
ANCOVA
0.409
LS Mean difference
-2.670
2-Sided
95
-9.053
3.712
No
Superiority or Other
OG002
OG005
ANCOVA
0.161
LS Mean difference
-4.526
2-Sided
95
-10.888
1.835
No
Superiority or Other
OG003
OG005
ANCOVA
0.396
LS Mean difference
-2.867
2-Sided
95
-9.543
3.810
No
Superiority or Other
OG004
OG005
ANCOVA
0.365
LS Mean difference
-3.780
2-Sided
95
-12.028
4.467
No
Superiority or Other
OG00060
OG00155
Title
Denominators
Categories
Title
Measurements
OG000-1.23± 0.801
OG001-0.62± 0.829
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
Mixed Model Repeated Measure (MMRM)
0.5978
LS Mean difference
0.60
2-Sided
95
-1.66
2.86
No
Superiority or Other
36
OG00117
Title
Denominators
Categories
Title
Measurements
OG000-4.442(-7.141 to -1.742)
OG001-1.668(-5.606 to 2.271)
OG004
Cohort 3: LUM 400 mg q12h - Period 1
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28).
OG005
Cohort 2 and 3: Placebo (HO and HE) - Period 1
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28).
Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
OG005
Cohort 2 and 3: Placebo (HO and HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
OG005
Cohort 2 and 3: Placebo (HO and HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
Units
Counts
Participants
OG00021
OG00120
OG00220
OG00317
OG00410
OG00524
Title
Denominators
Categories
Title
Measurements
OG0003.13(-1.29 to 7.54)
OG0012.98(-1.52 to 7.48)
OG0029.70(5.17 to 14.23)
OG0034.30(-0.59 to 9.19)
OG0048.24(1.83 to 14.65)
OG005-2.05(-6.25 to 2.15)
Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants heterozygous (HE) for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
OG005
Cohort 2 and 3: Placebo (HO and HE)
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
Units
Counts
Participants
OG00023
OG00121
OG00221
OG00321
OG00411
OG00527
Title
Denominators
Categories
Day 28: (n= 21, 20, 20, 18, 11, 27)
Title
Measurements
OG0000.21(-2.77 to 3.19)
OG001-1.35(-4.39 to 1.69)
OG002-2.62(-5.67 to 0.42)
OG003-3.82(-7.03 to -0.61)
OG004-4.52(-8.65 to -0.39)
OG005-0.03(-2.68 to 2.62)
Day 56: (n= 21, 20, 20, 17, 10, 24)
Title
Measurements
OG0001.82(-1.28 to 4.91)
OG0010.64(-2.52 to 3.80)
OG0023.59(0.41 to 6.77)
OG003
Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants heterozygous (HE) for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
OG005
Cohort 2 and 3: Placebo (HO and HE)
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
Units
Counts
Participants
OG00023
OG00121
OG00221
OG00321
OG00411
OG00527
Title
Denominators
Categories
Day 28: (n= 21, 20, 20, 18, 11, 27)
Title
Measurements
OG0000.24(-4.27 to 4.75)
OG001-1.15(-5.75 to 3.45)
OG002-3.13(-7.74 to 1.48)
OG003-5.46(-10.32 to -0.60)
OG004-6.39(-12.65 to -0.14)
OG0051.89(-2.12 to 5.90)
Day 56: (n= 21, 20, 20, 17, 10, 24)
Title
Measurements
OG0002.51(-2.21 to 7.23)
OG0011.72(-3.09 to 6.53)
OG0025.55(0.70 to 10.39)
OG003
60
OG00155
Title
Denominators
Categories
Title
Measurements
OG000-2.20± 1.373
OG001-0.69± 1.423
Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
OG005
Cohort 2 and 3: Placebo (HO and HE) - Period 2
Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).