PF-00489791 For The Treatment Of Raynaud's | NCT01090492 | Trialant
NCT01090492
Sponsor
Pfizer
Status
Completed
Last Update Posted
May 16, 2018Actual
Enrollment
243Actual
Phase
Phase 2
Conditions
Raynaud's Disease
Peripheral Vascular Disease
Interventions
PF-00489791
PF-00489791
PF-00489791
PF-00489791
PF-00489791
PF-00489791
PF-00489791
PF-00489791
Countries
United States
Canada
Colombia
Czechia
Germany
Hungary
Mexico
Poland
South Korea
Spain
Sweden
Protocol Section
Identification Module
NCT ID
NCT01090492
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
A7331010
Secondary IDs
ID
Type
Description
Link
EudraCT 2010-019009-40
2010-019009-40
EudraCT Number
Brief Title
PF-00489791 For The Treatment Of Raynaud's
Official Title
A Phase 2a Randomized Double-blinded, Placebo And Active Controlled Two Cohort Two Doses Cross-over Multi-center Clinical Study To Assess Efficacy Of A Once Daily Administration Of A Phosphodiesterase 5 Inhibitor (Pf-00489791) For The Treatment Of Vasospasm In Primary And Secondary Raynaud's Phenomenon
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Apr 2018
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
Aug 4, 2010Actual
Primary Completion Date
May 31, 2011Actual
Completion Date
May 31, 2011Actual
First Submitted Date
Mar 18, 2010
First Submission Date that Met QC Criteria
Mar 18, 2010
First Posted Date
Mar 22, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 15, 2017
Results First Submitted that Met QC Criteria
Apr 16, 2018
Results First Posted Date
May 16, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Nov 9, 2012
Certification/Extension First Submitted that Passed QC Review
Nov 9, 2012
Certification/Extension First Posted Date
Nov 16, 2012Estimated
Last Update Submitted Date
Apr 16, 2018
Last Update Posted Date
May 16, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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 investigators propose that once daily administration of PF-00489791, a phosphodiesterase inhibitor, will reduce vasospasm and improve symptoms and signs associated with Primary and Secondary Raynaud's Phenomenon.
Detailed Description
Not provided
Conditions Module
Conditions
Raynaud's Disease
Peripheral Vascular Disease
Keywords
Raynaud's phenomenon
vasospasm
scleroderma
systemic sclerosis
CREST
phosphodiesterase inhibitor
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
243Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Secondary Raynaud 4 mg dose (period 1)
Experimental
Drug: PF-00489791
Secondary Raynaud 4 mg dose (period 2)
Experimental
Drug: PF-00489791
Secondary Raynaud 20 mg dose (period 1)
Experimental
Drug: PF-00489791
Secondary Raynaud 20 mg dose (period 2)
Experimental
Drug: PF-00489791
Primary Raynaud 4 mg dose (period 1)
Experimental
Drug: PF-00489791
Primary Raynaud 4 mg dose (period 2)
Experimental
Drug: PF-00489791
Primary Raynaud 20 mg dose (period 1)
Experimental
Drug: PF-00489791
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PF-00489791
Drug
Subjects with Secondary Raynaud's Phenomenon will receive PF-00489791 4 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Mean Raynaud's Condition Score (RCS) at Week 4
The Raynaud's Condition score (RCS) is participant's rating of difficulty considering number of attacks, duration, amount of pain, numbness, or other symptoms caused in the fingers (including painful sores) due to the Raynaud's phenomenon every day and impact of Raynaud's alone on use of hands every day. An 11 point Likert scale is used to rate the difficulty caused by the condition each day with 0 = no difficulty and 10 = extreme difficulty. Participants were asked to select the number that best describes their difficulty, with higher score indicating worse condition. Average daily score was considered for participants completing more than 1 Raynaud's pain score scale on a day. Baseline value was calculated as mean of the scores over 7 days prior to treatment start. Week 4 value was calculated as mean of the scores over the 7-day period prior to Week 4.
Baseline, Week 4
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in the Number of Raynaud's Attacks at Week 1, 2, 3 and 4
Change from baseline in the number of Raynaud's attacks at Week 1, Week 2, Week 3 and Week 4 was calculated from the number of attacks reported over the 7-day period prior to each week from the patient diary, respectively.
Baseline, Week 1, Week 2, Week 3, Week 4
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Active Raynaud's Phenomenon
Stable disease and medication requirements over the previous two months
For Secondary Raynaud's Phenomenon subjects, a diagnosis of scleroderma using the American College of Rheumatology criteria or by the presence of at least 3/5 features of CREST syndrome
both sexes
Exclusion Criteria:
Uncontrolled hypertension, diabetes mellitus, angina, or using oral nitrates
Smoking within 3 months or smoking cessation using nicotine products
Subjects currently taking sildenafil, tadalafil or vardenafil
Subjects with ulnar arterial occlusive disease as shown by a modified Allen test
Pregnant or breast feeding or considering pregnancy in next 4 months
Participation in trial for investigational drug within 30 days
Su KY, Sharma M, Kim HJ, Kaganov E, Hughes I, Abdeen MH, Ng JHK. Vasodilators for primary Raynaud's phenomenon. Cochrane Database Syst Rev. 2021 May 17;5(5):CD006687. doi: 10.1002/14651858.CD006687.pub4.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
A total of 243 participants were stratified into 2 cohorts (Primary Raynaud's phenomenon[PRP] and secondary RP[SRP]), who entered a 2-week placebo run-in period (to establish baseline), followed by a cross-over period (first 4 week treatment period,then a 2 week placebo washout,then 4 week treatment period) and then a 2-week placebo run-out period.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
PRP Cohort: Placebo First, Then PF-00489791 4 mg
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 4 milligram (mg) (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
Periods
Title
Milestones
Reasons Not Completed
First Intervention Period (4 Weeks)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
0
More Info Module
Limitations and Caveats
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Argentina
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Primary Raynaud 20 mg dose (period 2)
Experimental
Drug: PF-00489791
Secondary Raynaud 4 mg dose (period 1)
PF-00489791
Drug
Subjects with Secondary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period and then PF-00489791 4 mg once a day for the second 4 week cross over period
Secondary Raynaud 4 mg dose (period 2)
PF-00489791
Drug
Subjects with Secondary Raynaud's Phenomenon will receive PF-00489791 20 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period
Secondary Raynaud 20 mg dose (period 1)
PF-00489791
Drug
Subjects with Secondary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period and then PF-00489791 20 mg once a day for the second 4 week cross over period
Secondary Raynaud 20 mg dose (period 2)
PF-00489791
Drug
Subjects with Primary Raynaud's Phenomenon will receive PF-00489791 4 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period
Primary Raynaud 4 mg dose (period 1)
PF-00489791
Drug
Subjects with Primary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period and then PF-00489791 4 mg once a day for the second 4 week cross over period
Primary Raynaud 4 mg dose (period 2)
PF-00489791
Drug
Subjects with Primary Raynaud's Phenomenon will receive PF-00489791 20 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period
Primary Raynaud 20 mg dose (period 1)
PF-00489791
Drug
Subjects with Primary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period and then PF-00489791 20 mg once a day for the second 4 week cross over period
Primary Raynaud 20 mg dose (period 2)
Change From Baseline in Mean Duration of Raynaud's Attacks at Week 4
Mean duration of Raynaud's attacks for a time period was calculated as sum of recorded durations of attacks in the time period divided by total number of attacks in the time period where duration was recorded.
Baseline, Week 4
Change From Baseline in the Mean Raynaud's Pain Score at Week 1, 2, 3 and 4
Participants were asked to rate their worst Raynaud's pain in the past 24 hours using an 11 point Likert scale, with 0 = no Raynaud's pain and 10 = the worst possible pain. Highest (most severe) response was considered for participants responding at more than 1 point on the scale. Average daily score was considered for participants completing more than 1 Raynaud's pain score scale on a day. Baseline value was calculated as mean of the scores over 7 days prior to treatment start. Post-baseline value was calculated as mean of the scores over the 7-day period prior to the visit.
Baseline, Week 1, 2, 3, 4
Number of Participants With Decrease From Baseline in Digital Ulcers at Day 14 and 28: Secondary Raynaud's Phenomenon Cohort
Presence of ulcer was assessed at baseline. At post-baseline visits, each ulcer was measured and scored: 1= smaller or improved compared to previous visit, 2= same as previous visit, 3= bigger or worse than previous visit, and 4= new. If a new digital ulcer develops during the course of the study, the measurement and scoring were initiated on this additional ulcer. Healed ulcers were not counted into the number of ulcers. Participants with SRP in the per-protocol population with at least 1 digital ulcer present at any assessment were evaluable for this measure. Results are reported for participants with presence of ulcer at baseline and decrease from baseline in ulcers at post-baseline visits.
Baseline, Day 14, 28
Plasma Concentration of PF-00489791 and Its Metabolites
Only participants receiving PF-00489791 were to be analyzed for this outcome. Data have been calculated by setting plasma concentration values below the lower limit of quantification to 0. The lower limit of quantification is 0.0100 microgram per milliliter (mcg/mL). Data for plasma concentration of PF-00489791 metabolites was not analyzed, as it was not intended to be a secondary endpoint and was deemed optional.
Day 1, 15, 29 (Day 1, 15, 29 for first intervention period), 43, 57, 71 (Day 1, 15, 29 for second intervention period)
Number of Participants With Laboratory Test Abnormalities
Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (less than [<] 0.8*lower limit of normal[LLN]); leukocytes (<0.6 LLN /greater than [>] 1.5*upper LN [ULN]; platelets (<0.5*LLN/>1.75*ULN); neutrophils, lymphocytes (<0.8* LLN/>1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), Gamma GT, alkaline phosphatase (>3*ULN); BUN, creatinine (>1.3*ULN); glucose (<0.6 LLN/>1.5*ULN); uric acid (>1.2*ULN); sodium (<0.95*LLN/>1.05*ULN); potassium, calcium, chloride, bicarbonate (<0.9*LLN/>1.1*ULN); albumin, total protein (<0.8*LLN/>1.2*ULN); creatine kinase (>2.0*ULN); Urine Specific Gravity, Urine pH, urine blood, urine glucose, urine protein, urine ketones, urine leukocytes esterase (>=1 high-powered field). Total number of participants with any laboratory abnormalities was reported.
Screening up to 28 days after last study dose (up to 98 days)
Number of Participants With Clinically Significant Changes in Vital Signs and Orthostatic Blood Pressure Measurements
Vital signs assessment included measurement of supine and standing pulse rate, systolic and diastolic blood pressures. Criteria for clinically significant vital signs and orthostatic blood pressure measurements were based on investigator's judgement.
Screening up to 28 days after last study dose (up to 98 days)
Number of Participants With Abnormal Electrocardiogram (ECG) Values
ECG assessment included measurement of PR, QRS, QT,corrected QT interval (QTc)values. Criteria for clinically significant ECG values were based on investigator's judgement.
Screening up to 28 days after last study dose (up to 98 days)
Farmington
Connecticut
06030-5353
United States
Georgetown University Hospital
Washington D.C.
District of Columbia
20007
United States
Arthritis and Rheumatology of Georgia
Atlanta
Georgia
30342
United States
Rockford Orthopedic Associates
Rockford
Illinois
61107
United States
Diagnostic Rheumatology and Research, PC
Indianapolis
Indiana
46227
United States
Memorial Health System, Inc. dba Memorial Medical Group Clinical Research Institute
South Bend
Indiana
46601
United States
Johns Hopkins University - Division of Rheumatology
Baltimore
Maryland
21224
United States
The Center for Rheumatology and Bone Research
Wheaton
Maryland
20902
United States
Clinical Pharmacology Study Group
Worcester
Massachusetts
01610
United States
University of Michigan
Ann Arbor
Michigan
48106
United States
University of Michigan Health System
Ann Arbor
Michigan
48109
United States
West Michigan Rheumatology, PLLC
Grand Rapids
Michigan
49546
United States
Physician Research Collaboration, LLC
Lincoln
Nebraska
68516
United States
UMDNJ - Robert Wood Johnson Medical Center Clinical Research Center
New Brunswick
New Jersey
08903-0019
United States
The Center for Rheumatology
Albany
New York
12206
United States
Regional Rheumatology Associates
Binghamton
New York
13905
United States
AAIR Research Center
Rochester
New York
14618
United States
East Penn Rheumatology Associates, PC
Bethlehem
Pennsylvania
18015
United States
Altoona Center for Clinical Research
Duncansville
Pennsylvania
16635
United States
Rheumatic Disease Associates, Ltd.
Willow Grove
Pennsylvania
19090
United States
Metroplex Clinical Research Center
Dallas
Texas
75231
United States
Rainier Clinical Research Center, Inc.
Renton
Washington
98057
United States
Arthritis Centre Health Sciences Centre
Winnipeg
Manitoba
R3A 1M4
Canada
St. Joseph's Health Centre
London
Ontario
N6A 4V2
Canada
Rheumatology Research Associates
Ottawa
Ontario
K1H 1A2
Canada
Sir Mortimer B. Davis, Jewish General Hospital
Montreal
Quebec
H3T 1E2
Canada
Centro Integral de Reumatologia e Inmunologia CIREI
Bogota
Cundinamarca
0000
Colombia
Fundacion Instituto de Reumatologia Fernando Chalem
Bogota
Cundinamarca
0000
Colombia
Idearg Sas
Bogotá
Cundinamarca
0000
Colombia
Servimed E.U
Bucaramanga
Santander Department
0000
Colombia
Medicity S.A.S
Bucaramanga
0000
Colombia
REVMATOLOGIE s.r.o.,
Brno
638 00
Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové
500 05
Czechia
Revmatologicky ustav
Prague
128 50
Czechia
Dermatologisches Ambulatorium Hamburg-Alstertal
Hamburg
22391
Germany
Semmelweis Egyetem, Ersebeszeti Klinika
Budapest
1122
Hungary
Bacs-Kiskun Megyei Onkormanyzat Korhaza Szegedi Tudomanyegyetem AOK Oktato Korhaza
Kecskemét
6000
Hungary
Vas Megyei Markusovszky Korhaz Nonprofit Zrt, Angiologiai Szakambulancia
Szombathely
9700
Hungary
Unidad de Investigacion en Enfermedades Cronico Degenerativas
Guadalajara
Jalisco
44620
Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City
Mexico City
14000
Mexico
Hospital Angeles. Centro Medico del Potosi
San Luis Potosí City
78200
Mexico
Slaskie Centrum Osteoporozy
Katowice
40-084
Poland
Prywatna Praktyka Lekarska Dr Med. Pawel Hrycaj
Poznan
61-397
Poland
Prywatna Praktyka Lekarska Prof. UM Dr hab. med. Pawel Hrycaj
Poznan
61-397
Poland
Katedra i Klinika Dermatologii, Wenerologii i Alergologii Akademii Medycznej we Wroclawiu
Wroclaw
50-368
Poland
Seoul National University Hospital, Rheumatology, Internal Medicine
Seoul
110-744
South Korea
Yonsei University College of Medicine, Severance Hospital, Rheumatology, Internal Medicine
Seoul
120-752
South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital/ Rheumatology, Internal Medicine
Seoul
137-701
South Korea
Hospital Clinico Universitario Santiago de Compostela
Santiago de Compostela
A Coruña
15706
Spain
Hospital Del Mar
Barcelona
08003
Spain
Hospital Universitario 12 de Octubre
Madrid
28041
Spain
CTC, Centrum för klinisk provning, Sahlgrenska Universitetssjukhuset
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
FG002
PRP Cohort: Placebo First, Then PF-00489791 20 mg
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
FG003
PRP Cohort: PF-00489791 20 mg First, Then Placebo
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
FG004
SRP Cohort: Placebo First, Then PF-00489791 4 mg
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 4 milligram (mg) (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
FG005
SRP Cohort: PF-00489791 4 mg First, Then Placebo
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
FG006
SRP Cohort: Placebo First, Then PF-00489791 20 mg
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
FG007
SRP Cohort: PF-00489791 20 mg First, Then Placebo
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
FG00027 subjects
FG00129 subjects
FG00229 subjects
FG00328 subjects
FG00433 subjects
FG00532 subjects
FG00632 subjects
FG00733 subjects
COMPLETED
FG00026 subjects
FG00124 subjects
FG00226 subjects
FG00322 subjects
FG00429 subjects
FG00530 subjects
FG00631 subjects
FG00727 subjects
NOT COMPLETED
FG0001 subjects
FG0015 subjects
FG0023 subjects
FG0036 subjects
FG0044 subjects
FG0052 subjects
FG0061 subjects
FG0076 subjects
Type
Comment
Reasons
Protocol Violation
FG0001 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
Did not meet inclusion criteria
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Other
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0031 subjects
FG004
Pregnancy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Adverse Event
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0033 subjects
FG004
Placebo Washout Period ( 2 Weeks)
Type
Comment
Milestone Data
STARTED
FG00026 subjects
FG00124 subjects
FG00226 subjects
FG00322 subjects
FG00429 subjects
FG00530 subjects
FG00631 subjects
FG00727 subjects
COMPLETED
FG00026 subjects
FG00124 subjects
FG00226 subjects
FG00322 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Second Intervention Period (4 Weeks)
Type
Comment
Milestone Data
STARTED
FG00026 subjects
FG00124 subjects
FG00226 subjects
FG00322 subjects
FG00429 subjects
FG00530 subjects
FG00631 subjects
FG00727 subjects
COMPLETED
FG00025 subjects
FG00122 subjects
FG00224 subjects
FG00322 subjects
FG004
NOT COMPLETED
FG0001 subjects
FG0012 subjects
FG0022 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG003
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
PRP Cohort: Placebo First, Then PF-00489791 4 mg
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 4 milligram (mg) (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
BG001
PRP Cohort: PF-00489791 4mg First, Then Placebo
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first intervention DB period and 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second DB intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
BG002
PRP Cohort: Placebo First, Then PF-00489791 20 mg
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in second DB intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
BG003
PRP Cohort: PF-00489791 20 mg First, Then Placebo
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with PRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
BG004
SRP Cohort: Placebo First, Then PF-00489791 4 mg
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 4 milligram (mg) (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
BG005
SRP Cohort: PF-00489791 4 mg First, Then Placebo
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
BG006
SRP Cohort: Placebo First, Then PF-00489791 20 mg
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first intervention period and then PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
BG007
SRP Cohort: PF-00489791 20 mg First, Then Placebo
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first intervention period and then 2 placebo tablets matched to PF-00489791 orally once daily for 4 weeks in second intervention period to participants with SRP. A washout period of 2 weeks was maintained between each intervention period during which 2 placebo tablets matched to PF-00489791 were given orally once daily.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00027
BG00129
BG00229
BG00328
BG00433
BG00532
BG00632
BG00733
BG008243
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Between 18 to 44 years
BG00014
BG00112
BG00214
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00025
BG00125
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
Change From Baseline in Mean Raynaud's Condition Score (RCS) at Week 4
The Raynaud's Condition score (RCS) is participant's rating of difficulty considering number of attacks, duration, amount of pain, numbness, or other symptoms caused in the fingers (including painful sores) due to the Raynaud's phenomenon every day and impact of Raynaud's alone on use of hands every day. An 11 point Likert scale is used to rate the difficulty caused by the condition each day with 0 = no difficulty and 10 = extreme difficulty. Participants were asked to select the number that best describes their difficulty, with higher score indicating worse condition. Average daily score was considered for participants completing more than 1 Raynaud's pain score scale on a day. Baseline value was calculated as mean of the scores over 7 days prior to treatment start. Week 4 value was calculated as mean of the scores over the 7-day period prior to Week 4.
Per-protocol analysis set (PPAS) included all randomized participants compliant with diary completion and were not amongst serious protocol violators, receiving study medication till the study completion.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 4
ID
Title
Description
OG000
PF-00489791 4 mg (PRP)
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
OG001
PF-00489791 20 mg (PRP)
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
OG002
Placebo (PRP)
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
OG003
PF-00489791 4 mg (SRP)
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
OG004
PF-00489791 20 mg (SRP)
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
OG005
Placebo (SRP)
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
Units
Counts
Participants
OG00034
OG00139
OG00273
OG003
Title
Denominators
Categories
Baseline
Title
Measurements
OG0003.04± 1.899
OG0012.90± 2.160
OG0022.98± 1.958
OG003
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
PRP: Adjusted mean difference analysis was based on Analysis of Covariance (ANCOVA) model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.
ANCOVA
0.6513
Adjusted Mean Difference
0.11
2-Sided
80
-0.21
0.44
Superiority or Other
OG001
Secondary
Change From Baseline in the Number of Raynaud's Attacks at Week 1, 2, 3 and 4
Change from baseline in the number of Raynaud's attacks at Week 1, Week 2, Week 3 and Week 4 was calculated from the number of attacks reported over the 7-day period prior to each week from the patient diary, respectively.
PPAS included all randomized participants compliant with diary completion and were not amongst serious protocol violators, receiving study medication till the study completion. Here, number analyzed signifies those participants who were evaluable at specified time points.
Posted
Mean
Standard Deviation
Raynaud's attacks
Baseline, Week 1, Week 2, Week 3, Week 4
ID
Title
Description
OG000
PF-00489791 4 mg (PRP)
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
OG001
PF-00489791 20 mg (PRP)
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
OG002
Placebo (PRP)
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
Secondary
Change From Baseline in Mean Duration of Raynaud's Attacks at Week 4
Mean duration of Raynaud's attacks for a time period was calculated as sum of recorded durations of attacks in the time period divided by total number of attacks in the time period where duration was recorded.
PPAS included all randomized participants compliant with diary completion and were not amongst serious protocol violators, receiving study medication till the study completion. Here, number analyzed signifies those participants who were evaluable at specified time points.
Posted
Mean
Standard Deviation
minutes per attack
Baseline, Week 4
ID
Title
Description
OG000
PF-00489791 4 mg (PRP)
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
OG001
PF-00489791 20 mg (PRP)
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
OG002
Placebo (PRP)
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
Secondary
Change From Baseline in the Mean Raynaud's Pain Score at Week 1, 2, 3 and 4
Participants were asked to rate their worst Raynaud's pain in the past 24 hours using an 11 point Likert scale, with 0 = no Raynaud's pain and 10 = the worst possible pain. Highest (most severe) response was considered for participants responding at more than 1 point on the scale. Average daily score was considered for participants completing more than 1 Raynaud's pain score scale on a day. Baseline value was calculated as mean of the scores over 7 days prior to treatment start. Post-baseline value was calculated as mean of the scores over the 7-day period prior to the visit.
PPAS included all randomized participants compliant with diary completion and were not amongst serious protocol violators, receiving study medication till the study completion. Here, number analyzed signifies those participants who were evaluable at specified time points.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 1, 2, 3, 4
ID
Title
Description
OG000
PF-00489791 4 mg (PRP)
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
OG001
PF-00489791 20 mg (PRP)
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
Secondary
Number of Participants With Decrease From Baseline in Digital Ulcers at Day 14 and 28: Secondary Raynaud's Phenomenon Cohort
Presence of ulcer was assessed at baseline. At post-baseline visits, each ulcer was measured and scored: 1= smaller or improved compared to previous visit, 2= same as previous visit, 3= bigger or worse than previous visit, and 4= new. If a new digital ulcer develops during the course of the study, the measurement and scoring were initiated on this additional ulcer. Healed ulcers were not counted into the number of ulcers. Participants with SRP in the per-protocol population with at least 1 digital ulcer present at any assessment were evaluable for this measure. Results are reported for participants with presence of ulcer at baseline and decrease from baseline in ulcers at post-baseline visits.
PPAS included all randomized participants compliant with diary completion and were not amongst serious protocol violators, receiving study medication till the study completion. Here, number analyzed signifies those participants who were evaluable at specified time points.
Posted
Number
participants
Baseline, Day 14, 28
ID
Title
Description
OG000
PF-00489791 4 mg (SRP)
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
OG001
PF-00489791 20 mg (SRP)
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
Secondary
Plasma Concentration of PF-00489791 and Its Metabolites
Only participants receiving PF-00489791 were to be analyzed for this outcome. Data have been calculated by setting plasma concentration values below the lower limit of quantification to 0. The lower limit of quantification is 0.0100 microgram per milliliter (mcg/mL). Data for plasma concentration of PF-00489791 metabolites was not analyzed, as it was not intended to be a secondary endpoint and was deemed optional.
Analysis population included participants who received 1 dose of study drug and were analyzed for pharmacokinetic parameters. Here, Overall number of participants signifies participants evaluable for either first or second intervention period and number analyzed signifies those participants who were evaluable at specified time points.
Posted
Mean
Standard Deviation
mcg/mL
Day 1, 15, 29 (Day 1, 15, 29 for first intervention period), 43, 57, 71 (Day 1, 15, 29 for second intervention period)
ID
Title
Description
OG000
PF-00489791 4 mg (PRP)
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
OG001
PF-00489791 20 mg (PRP)
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
Secondary
Number of Participants With Laboratory Test Abnormalities
Criteria for laboratory tests abnormalities included: hemoglobin, hematocrit and red blood cells (less than [<] 0.8*lower limit of normal[LLN]); leukocytes (<0.6 LLN /greater than [>] 1.5*upper LN [ULN]; platelets (<0.5*LLN/>1.75*ULN); neutrophils, lymphocytes (<0.8* LLN/>1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); bilirubin (>1.5*ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), Gamma GT, alkaline phosphatase (>3*ULN); BUN, creatinine (>1.3*ULN); glucose (<0.6 LLN/>1.5*ULN); uric acid (>1.2*ULN); sodium (<0.95*LLN/>1.05*ULN); potassium, calcium, chloride, bicarbonate (<0.9*LLN/>1.1*ULN); albumin, total protein (<0.8*LLN/>1.2*ULN); creatine kinase (>2.0*ULN); Urine Specific Gravity, Urine pH, urine blood, urine glucose, urine protein, urine ketones, urine leukocytes esterase (>=1 high-powered field). Total number of participants with any laboratory abnormalities was reported.
Analysis population included all randomized participants who took at least 1 dose of study medication along with at least 1 on-treatment laboratory test result.
Posted
Number
participants
Screening up to 28 days after last study dose (up to 98 days)
ID
Title
Description
OG000
PF-00489791 4 mg (PRP)
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
OG001
PF-00489791 20 mg (PRP)
Secondary
Number of Participants With Clinically Significant Changes in Vital Signs and Orthostatic Blood Pressure Measurements
Vital signs assessment included measurement of supine and standing pulse rate, systolic and diastolic blood pressures. Criteria for clinically significant vital signs and orthostatic blood pressure measurements were based on investigator's judgement.
Safety analysis set consisted of all participants who took at least 1 dose of study medication.
Posted
Number
participants
Screening up to 28 days after last study dose (up to 98 days)
ID
Title
Description
OG000
PF-00489791 4 mg (PRP)
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
OG001
PF-00489791 20 mg (PRP)
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
OG002
Placebo (PRP)
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
Secondary
Number of Participants With Abnormal Electrocardiogram (ECG) Values
ECG assessment included measurement of PR, QRS, QT,corrected QT interval (QTc)values. Criteria for clinically significant ECG values were based on investigator's judgement.
Safety analysis set consisted of all participants who took at least 1 dose of study medication.
Posted
Number
participants
Screening up to 28 days after last study dose (up to 98 days)
ID
Title
Description
OG000
PF-00489791 4 mg (PRP)
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
OG001
PF-00489791 20 mg (PRP)
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
OG002
Placebo (PRP)
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
OG003
PF-00489791 4 mg (SRP)
Time Frame
Not provided
Description
Safety analysis population included all participants who received at least 1 dose of study medication.
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
PF-00489791 4 mg (PRP)
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
0
55
0
55
27
55
EG001
PF-00489791 20 mg (PRP)
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
0
54
0
54
34
54
EG002
Placebo (PRP)
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
0
102
0
102
43
102
EG003
PF-00489791 4 mg (SRP)
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
0
61
0
61
34
61
EG004
PF-00489791 20 mg (SRP)
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
0
64
0
64
51
64
EG005
Placebo (SRP)
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
1
122
1
122
60
122
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Oesophageal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG0030 affected61 at risk
EG004
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected102 at risk
EG0030 affected61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0021 affected102 at risk
EG003
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Neutropenia
Blood and lymphatic system disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Palpitations
Cardiac disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0022 affected102 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Cystic fibrosis
Congenital, familial and genetic disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Ear pain
Ear and labyrinth disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Tinnitus
Ear and labyrinth disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0021 affected102 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0021 affected102 at risk
EG003
Dry eye
Eye disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Eye discharge
Eye disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected102 at risk
EG003
Eye oedema
Eye disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Eye pruritus
Eye disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Eyelid oedema
Eye disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Lacrimation increased
Eye disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Ocular hyperaemia
Eye disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected102 at risk
EG003
Periorbital oedema
Eye disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Photophobia
Eye disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Vision blurred
Eye disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0021 affected102 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Abdominal distension
Gastrointestinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0021 affected102 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0002 affected55 at risk
EG0010 affected54 at risk
EG0021 affected102 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0002 affected55 at risk
EG0010 affected54 at risk
EG0024 affected102 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0022 affected102 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0015 affected54 at risk
EG0020 affected102 at risk
EG003
Dysphagia
Gastrointestinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0021 affected102 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0021 affected102 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected102 at risk
EG003
Gingivitis
Gastrointestinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0005 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Oesophageal pain
Gastrointestinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected102 at risk
EG003
Oesophagitis
Gastrointestinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Salivary gland calculus
Gastrointestinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Toothache
Gastrointestinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0002 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Adverse drug reaction
General disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Asthenia
General disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0012 affected54 at risk
EG0020 affected102 at risk
EG003
Chest pain
General disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Face oedema
General disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Fatigue
General disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0023 affected102 at risk
EG003
Feeling hot
General disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0023 affected102 at risk
EG003
Inflammation
General disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Influenza like illness
General disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Malaise
General disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0011 affected54 at risk
EG0021 affected102 at risk
EG003
Oedema
General disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Oedema peripheral
General disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0012 affected54 at risk
EG0022 affected102 at risk
EG003
Pain
General disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0011 affected54 at risk
EG0020 affected102 at risk
EG003
Pyrexia
General disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0021 affected102 at risk
EG003
Ulcer
General disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0021 affected102 at risk
EG003
Alveolar osteitis
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Bacteriuria
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Bronchitis
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected102 at risk
EG003
Cystitis
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected102 at risk
EG003
Furuncle
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0021 affected102 at risk
EG003
Gastrointestinal infection
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Influenza
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected102 at risk
EG003
Laryngitis
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Localised infection
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0003 affected55 at risk
EG0012 affected54 at risk
EG0023 affected102 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Oral herpes
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected102 at risk
EG003
Otitis externa
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Otitis media
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Pharyngotonsillitis
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0021 affected102 at risk
EG003
Rash pustular
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Sialoadenitis
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Sinusitis
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0002 affected55 at risk
EG0011 affected54 at risk
EG0022 affected102 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected102 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Tooth infection
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG00210 affected102 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Vaginitis bacterial
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Viral infection
Infections and infestations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0021 affected102 at risk
EG003
Frostbite
Injury, poisoning and procedural complications
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected102 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected102 at risk
EG003
Blood potassium increased
Investigations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Blood pressure increased
Investigations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Electrocardiogram abnormal
Investigations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Gamma-glutamyltransferase increased
Investigations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Heart rate increased
Investigations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Transaminases increased
Investigations
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0021 affected102 at risk
EG003
Weight increased
Investigations
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Decreased appetite
Metabolism and nutrition disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0012 affected54 at risk
EG0020 affected102 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0012 affected54 at risk
EG0021 affected102 at risk
EG003
Fibromyalgia
Musculoskeletal and connective tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0021 affected102 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected102 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0011 affected54 at risk
EG0020 affected102 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0022 affected102 at risk
EG003
Musculoskeletal stiffness
Musculoskeletal and connective tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected102 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0002 affected55 at risk
EG0013 affected54 at risk
EG0021 affected102 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0021 affected102 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0002 affected55 at risk
EG0013 affected54 at risk
EG0022 affected102 at risk
EG003
Pain in jaw
Musculoskeletal and connective tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Polyarthritis
Musculoskeletal and connective tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Sensation of heaviness
Musculoskeletal and connective tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Synovitis
Musculoskeletal and connective tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Tendonitis
Musculoskeletal and connective tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Benign neoplasm of cornea
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Balance disorder
Nervous system disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Dizziness
Nervous system disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0011 affected54 at risk
EG0021 affected102 at risk
EG003
Headache
Nervous system disorders
MedDRA v14.1
Non-systematic Assessment
EG0008 affected55 at risk
EG00114 affected54 at risk
EG0029 affected102 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected102 at risk
EG003
Migraine
Nervous system disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0021 affected102 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0021 affected102 at risk
EG003
Parosmia
Nervous system disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Sciatica
Nervous system disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Sinus headache
Nervous system disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0022 affected102 at risk
EG003
Syncope
Nervous system disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Tremor
Nervous system disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0021 affected102 at risk
EG003
Depression
Psychiatric disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0021 affected102 at risk
EG003
Mood swings
Psychiatric disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected102 at risk
EG003
Orgasm abnormal
Psychiatric disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Proteinuria
Renal and urinary disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Renal impairment
Renal and urinary disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Erection increased
Reproductive system and breast disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Menstruation irregular
Reproductive system and breast disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Metrorrhagia
Reproductive system and breast disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Nipple pain
Reproductive system and breast disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Spontaneous penile erection
Reproductive system and breast disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Vaginal haemorrhage
Reproductive system and breast disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected102 at risk
EG003
Allergic bronchitis
Respiratory, thoracic and mediastinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0021 affected102 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Nasal congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Nasal obstruction
Respiratory, thoracic and mediastinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected102 at risk
EG003
Nasal ulcer
Respiratory, thoracic and mediastinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0012 affected54 at risk
EG0020 affected102 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected102 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected102 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected102 at risk
EG003
Vasomotor rhinitis
Respiratory, thoracic and mediastinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0021 affected102 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Acne cystic
Skin and subcutaneous tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0021 affected102 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Increased tendency to bruise
Skin and subcutaneous tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Nail bed inflammation
Skin and subcutaneous tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Pain of skin
Skin and subcutaneous tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0021 affected102 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Rash erythematous
Skin and subcutaneous tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Skin burning sensation
Skin and subcutaneous tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Skin disorder
Skin and subcutaneous tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Skin lesion
Skin and subcutaneous tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0021 affected102 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected102 at risk
EG003
Flushing
Vascular disorders
MedDRA v14.1
Non-systematic Assessment
EG0003 affected55 at risk
EG0012 affected54 at risk
EG0021 affected102 at risk
EG003
Haematoma
Vascular disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Hot flush
Vascular disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected102 at risk
EG003
Hypertension
Vascular disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Hypotension
Vascular disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Peripheral ischaemia
Vascular disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Phlebitis superficial
Vascular disorders
MedDRA v14.1
Non-systematic Assessment
EG0001 affected55 at risk
EG0010 affected54 at risk
EG0020 affected102 at risk
EG003
Raynaud's phenomenon
Vascular disorders
MedDRA v14.1
Non-systematic Assessment
EG0000 affected55 at risk
EG0011 affected54 at risk
EG0020 affected102 at risk
EG003
Plasma concentration of PF-00489791 metabolites was not intended as secondary endpoint in the protocol and was considered as an exploratory endpoint.
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D011928
Raynaud Disease
D016491
Peripheral Vascular Diseases
D045743
Scleroderma, Diffuse
D012595
Scleroderma, Systemic
Ancestor Terms
ID
Term
D000090122
Livedoid Vasculopathy
D013927
Thrombosis
D016769
Embolism and Thrombosis
D014652
Vascular Diseases
D002318
Cardiovascular Diseases
D017445
Skin Diseases, Vascular
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
D003240
Connective Tissue Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000619499
PF-00489791
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
2 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
1 subjects
FG0052 subjects
FG0060 subjects
FG0075 subjects
29 subjects
FG00530 subjects
FG00631 subjects
FG00727 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
27 subjects
FG00529 subjects
FG00622 subjects
FG00725 subjects
2 subjects
FG0051 subjects
FG0069 subjects
FG0072 subjects
0 subjects
FG0041 subjects
FG0050 subjects
FG0061 subjects
FG0071 subjects
Non-compliance
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Other
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
FG0067 subjects
FG0071 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
14
BG00410
BG0056
BG00616
BG0079
BG00895
Between 45 to 64 years
BG00013
BG00116
BG00215
BG00314
BG00422
BG00526
BG00616
BG00724
BG008146
Greater than or equal to (>=) 65 years
BG0000
BG0011
BG0020
BG0030
BG0041
BG0050
BG0060
BG0070
BG0082
25
BG00326
BG00430
BG00530
BG00631
BG00728
BG008220
Male
BG0002
BG0014
BG0024
BG0032
BG0043
BG0052
BG0061
BG0075
BG00823
47
OG00436
OG00583
3.14
± 2.431
OG0042.53± 1.833
OG0052.97± 2.492
Change at Week 4
Title
Measurements
OG000-0.76± 1.901
OG001-1.05± 1.771
OG002-0.61± 1.404
OG003-0.82± 1.624
OG004-0.15± 1.090
OG005-0.24± 1.437
OG002
PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.
ANCOVA
0.0057
Adjusted Mean Difference
-0.69
2-Sided
80
-0.99
-0.38
Superiority or Other
OG003
OG005
SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.
ANCOVA
0.1157
Adjusted Mean Difference
-0.44
2-Sided
80
-0.80
-0.08
Superiority or Other
OG004
OG005
SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.
ANCOVA
0.6286
Adjusted Mean Difference
-0.15
2-Sided
80
-0.56
0.25
Superiority or Other
OG003
PF-00489791 4 mg (SRP)
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
OG004
PF-00489791 20 mg (SRP)
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
OG005
Placebo (SRP)
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
Units
Counts
Participants
OG00034
OG00139
OG00273
OG00347
OG00436
OG00583
Title
Denominators
Categories
Baseline
ParticipantsOG00034
ParticipantsOG00139
ParticipantsOG00273
ParticipantsOG00347
ParticipantsOG00436
ParticipantsOG00583
Title
Measurements
OG00022.06± 20.587
OG00116.31± 10.885
OG00220.19± 17.802
OG003
Change at Week 1
ParticipantsOG00034
ParticipantsOG00139
ParticipantsOG00273
ParticipantsOG00347
Change at Week 2
ParticipantsOG00034
ParticipantsOG00139
ParticipantsOG00273
ParticipantsOG00347
Change at Week 3
ParticipantsOG00034
ParticipantsOG00139
ParticipantsOG00273
ParticipantsOG00347
Change at Week 4
ParticipantsOG00034
ParticipantsOG00139
ParticipantsOG00273
ParticipantsOG00347
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
At Week 4 - PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.
ANCOVA
0.9504
Adjusted Mean Difference
0.12
2-Sided
80
-2.43
2.68
Superiority or Other
OG001
OG002
At Week 4 - PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.
ANCOVA
0.4651
Adjusted Mean Difference
-1.35
2-Sided
80
-3.74
1.03
Superiority or Other
OG003
OG005
At Week 4 - SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.
ANCOVA
0.7423
Adjusted Mean Difference
-0.59
2-Sided
80
-2.92
1.73
Superiority or Other
OG004
OG005
At Week 4 - SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.
ANCOVA
0.3524
Adjusted Mean Difference
-1.91
2-Sided
80
-4.55
0.73
Superiority or Other
OG003
PF-00489791 4 mg (SRP)
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
OG004
PF-00489791 20 mg (SRP)
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
OG005
Placebo (SRP)
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
Units
Counts
Participants
OG00034
OG00139
OG00273
OG00347
OG00436
OG00583
Title
Denominators
Categories
Baseline
ParticipantsOG00034
ParticipantsOG00139
ParticipantsOG00273
ParticipantsOG00347
ParticipantsOG00436
ParticipantsOG00583
Title
Measurements
OG00017.69± 13.184
OG00122.23± 36.562
OG00219.61± 40.603
OG003
Change at Week 4
ParticipantsOG00034
ParticipantsOG00139
ParticipantsOG00273
ParticipantsOG00347
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
PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.
ANCOVA
0.7900
Adjusted Mean Difference
1.21
2-Sided
80
-4.61
7.03
Superiority or Other
OG001
OG002
PRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.
ANCOVA
0.1463
Adjusted Mean Difference
-6.17
2-Sided
80
-11.61
-0.73
Superiority or Other
OG003
OG005
SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.
ANCOVA
0.1446
Adjusted Mean Difference
-2.37
2-Sided
80
-4.44
-0.29
Superiority or Other
OG004
OG005
SRP: Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.
ANCOVA
0.5497
Adjusted Mean Difference
-1.09
2-Sided
80
-3.45
1.26
Superiority or Other
OG002
Placebo (PRP)
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
OG003
PF-00489791 4 mg (SRP)
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
OG004
PF-00489791 20 mg (SRP)
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
OG005
Placebo (SRP)
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
Units
Counts
Participants
OG00034
OG00139
OG00273
OG00347
OG00436
OG00583
Title
Denominators
Categories
Baseline
ParticipantsOG00034
ParticipantsOG00139
ParticipantsOG00273
ParticipantsOG00347
ParticipantsOG00436
ParticipantsOG00583
Title
Measurements
OG0002.84± 2.074
OG0012.78± 2.348
OG0022.80± 2.064
OG003
Change at Week 1
ParticipantsOG00034
ParticipantsOG00139
ParticipantsOG00273
ParticipantsOG00347
Change at Week 2
ParticipantsOG00034
ParticipantsOG00139
ParticipantsOG00273
ParticipantsOG00347
Change at Week 3
ParticipantsOG00034
ParticipantsOG00139
ParticipantsOG00273
ParticipantsOG00347
Change at Week 4
ParticipantsOG00034
ParticipantsOG00139
ParticipantsOG00273
ParticipantsOG00347
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
Week 4 (PRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.
ANCOVA
0.5909
Adjusted Mean Difference
0.15
2-Sided
80
-0.21
0.52
Superiority or Other
OG001
OG002
Week 4 (PRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.
ANCOVA
0.0053
Adjusted Mean Difference
-0.77
2-Sided
80
-1.12
-0.43
Superiority or Other
OG003
OG005
Week 4 (SRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.
ANCOVA
0.3462
Adjusted Mean Difference
-0.28
2-Sided
80
-0.67
0.10
Superiority or Other
OG004
OG005
Week 4 (SRP): Adjusted mean difference analysis was based on ANCOVA model with sequence, period and treatment as fixed effects and participant within sequence as a random effect, utilizing the baseline scores as covariate.
ANCOVA
0.1940
Adjusted Mean Difference
-0.44
2-Sided
80
-0.88
-0.01
Superiority or Other
OG002
Placebo (SRP)
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
Units
Counts
Participants
OG00047
OG00136
OG00283
Title
Denominators
Categories
Baseline
ParticipantsOG00047
ParticipantsOG00136
ParticipantsOG00279
Title
Measurements
OG00010
OG0017
OG00216
With Decrease at Day 14
ParticipantsOG00010
ParticipantsOG0017
ParticipantsOG00217
Title
Measurements
OG000
With Decrease at Day 28
ParticipantsOG00011
ParticipantsOG0018
ParticipantsOG00219
Title
Measurements
OG000
OG002
PF-00489791 4 mg (SRP)
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
OG003
PF-00489791 20 mg (SRP)
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
Units
Counts
Participants
OG00055
OG00154
OG00261
OG00364
Title
Denominators
Categories
Day 1
ParticipantsOG00029
ParticipantsOG00128
ParticipantsOG00232
ParticipantsOG00333
Title
Measurements
OG0000.0058± 0.0314
OG001NA± NANumber of observations above lower limit of quantification (NALQ) was 0, hence data could not be analyzed.
OG002NA± NANumber of observations above lower limit of quantification (NALQ) was 0, hence data was not summarized.
OG003
Day 15
ParticipantsOG00027
ParticipantsOG00124
ParticipantsOG00231
ParticipantsOG00328
Day 29
ParticipantsOG00024
ParticipantsOG00122
ParticipantsOG00231
ParticipantsOG00328
Day 43
ParticipantsOG00026
ParticipantsOG00126
ParticipantsOG00229
ParticipantsOG00331
Day 57
ParticipantsOG00025
ParticipantsOG00124
ParticipantsOG00227
ParticipantsOG00322
Day 71
ParticipantsOG00025
ParticipantsOG00124
ParticipantsOG00227
ParticipantsOG00331
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with PRP.
OG002
Placebo (PRP)
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with PRP.
OG003
PF-00489791 4 mg (SRP)
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
OG004
PF-00489791 20 mg (SRP)
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
OG005
Placebo (SRP)
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
Units
Counts
Participants
OG00050
OG00148
OG00298
OG00357
OG00460
OG005114
Title
Denominators
Categories
Title
Measurements
OG0002
OG0014
OG00214
OG0035
OG00413
OG00510
OG003
PF-00489791 4 mg (SRP)
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
OG004
PF-00489791 20 mg (SRP)
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
OG005
Placebo (SRP)
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
Units
Counts
Participants
OG00055
OG00154
OG002102
OG00361
OG00464
OG005122
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
PF-00489791 tablets 4 mg (2 tablets of PF-00489791 2 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
OG004
PF-00489791 20 mg (SRP)
PF-00489791 tablets 20 mg (2 tablets of PF-00489791 10 mg) orally once daily for 4 weeks in first or second intervention period to participants with SRP.
OG005
Placebo (SRP)
Two placebo tablets matched to PF-00489791 orally once daily for 4 weeks in first or second intervention period to participants with SRP.
Units
Counts
Participants
OG00055
OG00154
OG002102
OG00361
OG00464
OG005122
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
0 affected
64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
1 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
2 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0044 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0053 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
1 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
1 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0052 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
1 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0051 affected122 at risk
1 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0047 affected64 at risk
EG0050 affected122 at risk
1 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
2 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
1 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
1 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0043 affected64 at risk
EG0052 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0042 affected64 at risk
EG0053 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0042 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
1 affected
61 at risk
EG0041 affected64 at risk
EG0052 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0043 affected64 at risk
EG0050 affected122 at risk
3 affected
61 at risk
EG0043 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
1 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
1 affected
61 at risk
EG0040 affected64 at risk
EG0054 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
1 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
1 affected
61 at risk
EG0043 affected64 at risk
EG0054 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
1 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0042 affected64 at risk
EG0052 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
1 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0052 affected122 at risk
2 affected
61 at risk
EG0041 affected64 at risk
EG0055 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
1 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
1 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
1 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0051 affected122 at risk
2 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
2 affected
61 at risk
EG0045 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
2 affected
61 at risk
EG0040 affected64 at risk
EG0052 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
4 affected
61 at risk
EG0047 affected64 at risk
EG0053 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0042 affected64 at risk
EG0051 affected122 at risk
1 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
1 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
3 affected
61 at risk
EG0043 affected64 at risk
EG0054 affected122 at risk
9 affected
61 at risk
EG00421 affected64 at risk
EG00512 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
1 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
1 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
1 affected
61 at risk
EG0041 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
1 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
1 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
1 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0042 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0052 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0042 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0052 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
1 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
1 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
1 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0042 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0042 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
1 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
1 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0041 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
3 affected
61 at risk
EG0044 affected64 at risk
EG0051 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0051 affected122 at risk
1 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0052 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
1 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
0 affected
61 at risk
EG0040 affected64 at risk
EG0050 affected122 at risk
22.80
± 16.270
OG00423.70± 20.909
OG00523.08± 20.698
ParticipantsOG00436
ParticipantsOG00583
Title
Measurements
OG000-3.75± 7.494
OG001-2.47± 6.477
OG002-1.41± 7.934
OG003-3.17± 7.994
OG004-4.49± 14.692
OG005-2.36± 11.850
ParticipantsOG00436
ParticipantsOG00583
Title
Measurements
OG000-5.30± 9.487
OG001-2.36± 8.371
OG002-2.45± 11.107
OG003-3.76± 9.028
OG004-4.43± 17.312
OG005-1.87± 11.051
ParticipantsOG00436
ParticipantsOG00583
Title
Measurements
OG000-4.66± 10.559
OG001-4.86± 5.681
OG002-4.03± 10.396
OG003-4.25± 11.408
OG004-3.75± 8.601
OG005-1.93± 9.487
ParticipantsOG00436
ParticipantsOG00582
Title
Measurements
OG000-4.85± 13.008
OG001-3.07± 7.118
OG002-3.65± 10.460
OG003-3.89± 8.326
OG004-2.68± 10.002
OG005-2.25± 10.624
19.37
± 18.929
OG00419.07± 18.196
OG00519.91± 19.886
ParticipantsOG00436
ParticipantsOG00582
Title
Measurements
OG000-2.89± 7.480
OG001-5.63± 43.067
OG002-1.41± 12.348
OG003-3.92± 11.336
OG004-2.61± 9.593
OG005-1.65± 10.609
3.33
± 2.614
OG0042.54± 1.895
OG0053.10± 2.753
ParticipantsOG00436
ParticipantsOG00583
Title
Measurements
OG000-0.72± 1.525
OG001-0.74± 1.266
OG002-0.26± 1.205
OG003-0.53± 1.440
OG004-0.32± 1.276
OG005-0.17± 1.272
ParticipantsOG00436
ParticipantsOG00583
Title
Measurements
OG000-0.94± 1.745
OG001-0.61± 1.524
OG002-0.48± 1.337
OG003-0.68± 1.740
OG004-0.33± 1.321
OG005-0.24± 1.306
ParticipantsOG00436
ParticipantsOG00583
Title
Measurements
OG000-0.82± 1.720
OG001-1.12± 1.664
OG002-0.62± 1.262
OG003-0.80± 1.836
OG004-0.55± 1.081
OG005-0.33± 1.269
ParticipantsOG00436
ParticipantsOG00582
Title
Measurements
OG000-0.80± 1.842
OG001-1.14± 1.820
OG002-0.63± 1.423
OG003-0.77± 1.922
OG004-0.35± 1.115
OG005-0.27± 1.466
7
OG0011
OG0026
9
OG0015
OG0027
NA
± NA
Number of observations above lower limit of quantification (NALQ) was 0, hence data was not summarized.
Title
Measurements
OG0000.1523± 0.0855
OG0010.5907± 0.3736
OG0020.1756± 0.09038
OG0030.7718± 0.4991
Title
Measurements
OG0000.1489± 0.0854
OG0010.6525± 0.3822
OG0020.1776± 0.08508
OG0030.7577± 0.4137
Title
Measurements
OG000NA± NANumber of observations above lower limit of quantification (NALQ) was 0, hence data could not be analyzed.
OG001NA± NANumber of observations above lower limit of quantification (NALQ) was 0, hence data could not be analyzed.
OG002NA± NANumber of observations above lower limit of quantification (NALQ) was 0, hence data was not summarized.
OG003NA± NANumber of observations above lower limit of quantification (NALQ) was 0, hence data was not summarized.