Phase 3 Papulopustular Rosacea Study | NCT01494467 | Trialant
NCT01494467
Sponsor
Galderma R&D
Status
Completed
Last Update Posted
Feb 18, 2021Actual
Enrollment
688Actual
Phase
Phase 3
Conditions
Papulopustular Rosacea
Interventions
CD5024
Azelaic acid 15% Gel
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT01494467
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
RD.06.SPR.18171
Secondary IDs
Not provided
Brief Title
Phase 3 Papulopustular Rosacea Study
Official Title
A Phase 3 Randomized, Double Blind, 12 Week Vehicle Controlled, Parallel Group Study Assessing the Efficacy and Safety of CD5024 1 % Cream Versus Vehicle Cream in Subjects With Papulopustular Rosacea, Followed by a 40 Week Investigator Blinded Extension Comparing the Long Term Safety of CD5024 1% Cream Versus Azelaic Acid 15 % Gel.
Acronym
Not provided
Organization
Galderma R&DINDUSTRY
Status Module
Record Verification Date
Jan 2015
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 2011
Primary Completion Date
Aug 2013Actual
Completion Date
Aug 2013Actual
First Submitted Date
Dec 14, 2011
First Submission Date that Met QC Criteria
Dec 15, 2011
First Posted Date
Dec 19, 2011Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 8, 2015
Results First Submitted that Met QC Criteria
Jan 15, 2015
Results First Posted Date
Jan 16, 2015Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 27, 2014
Certification/Extension First Submitted that Passed QC Review
Jan 27, 2014
Certification/Extension First Posted Date
Feb 28, 2014Estimated
Last Update Submitted Date
Feb 16, 2021
Last Update Posted Date
Feb 18, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Galderma R&DINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to demonstrate that CD5024 1% cream is more effective than its vehicle when applied once daily, at bed time, during a 12 week period in subjects with Papulopustular Rosacea (PPR) and continues to be safe up to 12 months.
Detailed Description
Not provided
Conditions Module
Conditions
Papulopustular Rosacea
Keywords
PPR
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
688Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
CD5024
Experimental
CD5024 1% Cream
Drug: CD5024
CD5024 Vehicle
Placebo Comparator
CD5024 Vehicle Cream
Drug: Azelaic acid 15% Gel
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CD5024
Drug
CD5024 1% Cream, once daily
CD5024
Azelaic acid 15% Gel
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Success Rate
Percentage of subjects who achieve "Clear" (Score 0) or "Almost Clear" (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score.
Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale:
Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema)
Week 12
Absolute Change in Inflammatory Lesion Count
Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).
Baseline to Week 12
Secondary Outcomes
Measure
Description
Time Frame
Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)
Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).
Baseline to Week 12
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
The subject has papulopustular rosacea with an Investigator Global Assessment (IGA) score rated 3 (moderate) or 4 (severe),
The subject has at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face.
Exclusion Criteria:
The subject has particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial keratosis pilaris, seborrheic dermatitis, and acne,
The subject has rosacea with more than two nodules on the face.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Michael Graeber, M.D.
Galderma R&D, LLC
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Total Skin and Beauty
Birmingham
Alabama
35205
United States
Coastal Clinical Research, Inc.
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
CD5024 1% Cream
Part A & B: CD5024 1% Cream, once daily application
FG001
CD5024 Vehicle Cream/Azelaic Acid 15% Gel
Part A: CD5024 Vehicle Cream, once daily application
Part B: Azelaic acid 15% Gel, twice daily application
Periods
Title
Milestones
Reasons Not Completed
Part A Vehicle Control (12 Weeks)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
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
Not provided
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
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantCare ProviderInvestigator
Drug
Topical Gel applied twice daily
CD5024 Vehicle
Mobile
Alabama
36608
United States
Burke Pharmaceutical Research
Hot Springs
Arkansas
71913
United States
Dermatology Specialists, Inc
Oceanside
California
92056
United States
Integrated Research Group, Inc
Riverside
California
92506
United States
Therapeutics Clinical Research
San Diego
California
92123
United States
University of California, San Francisco
San Francisco
California
94143
United States
ATS Clinical Research
Santa Monica
California
90404
United States
Redwood Dermatology Research
Santa Rosa
California
95403
United States
FXM Research Corp Miami
Miami
Florida
33175
United States
Leavitt Medical Associates of Florida dba Ameriderm Research
Ormond Beach
Florida
United States
Atlanta Dermatology, Vein & Research Center, LLC
Alpharetta
Georgia
30022
United States
Emory University
Atlanta
Georgia
30322
United States
Altman Dermatology Associates
Arlington Heights
Illinois
60005
United States
Northwestern University
Chicago
Illinois
60611
United States
Deaconess Clinic, Inc.
Evansville
Indiana
47713
United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis
Indiana
46256
United States
Dermatology Specialists Research
Louisville
Kentucky
40202
United States
Northeast Dermatology Associates
Beverly
Massachusetts
01915
United States
David Fivenson, MD, PLC
Ann Arbor
Michigan
48103
United States
Hamzavi Dermatology
Fort Gratiot
Michigan
48059
United States
Somerset Skin Centre
Troy
Michigan
48084
United States
Dermatology Clinical Trials Unit
St Louis
Missouri
63141
United States
Psoriasis Treatment Center of NJ
West Windsor
New Jersey
United States
Academic Dermatology Associates
Albuquerque
New Mexico
87106
United States
DermResearch Center of New York, Inc
Stony Brook
New York
11790
United States
High Point
North Carolina
27262
United States
PMG Research of Raleigh, LLC
Raleigh
North Carolina
27609
United States
Oregon Dermatology and Research Center
Portland
Oregon
97210
United States
Dermatology and Skin Surgery Center
Exton
Pennsylvania
19341
United States
Philadelphia Institute of Dermatology
Fort Washington
Pennsylvania
19034
United States
Penn State Hershey Medical Center
Hershey
Pennsylvania
17033
United States
Paddington Research
Philadelphia
Pennsylvania
19103
United States
Yardley Dermatology Associates
Yardley
Pennsylvania
19067
United States
The Skin Wellness Center
Knoxville
Tennessee
37922
United States
Dermatology Reserach Associates
Nashville
Tennessee
17203
United States
Arlington Research Center, Inc
Arlington
Texas
76011
United States
Stephen Miller MD
San Antonio
Texas
78229
United States
San Antonio
Texas
78229
United States
Center for Clinical Studies
Webster
Texas
77598
United States
Guildford Dermatology Specialists
Surrey
British Columbia
V3R 6A7
Canada
Ultranova Skincare
Barrie
Ontario
L4M 6L2
Canada
Dermatrials Research
Hamilton
Ontario
L8N 1V6
Canada
The Guenther Dermatology Research Center
London
Ontario
N6A 3H7
Canada
Lynderm Research Inc
Markham
Ontario
L3P 1A8
Canada
North Bay Dermatology Centre, Inc
North Bay
Ontario
P1B 3Z7
Canada
The Centre for Dermatology & Cosmetic Surgery
Richmond Hill
Ontario
L4B 1A5
Canada
XLR8 Medical Research, Inc
Windsor
Ontario
N8W 1E6
Canada
International Dermatology Research, Inc
Montreal
Quebec
H3H 1V4
Canada
Centre de Recherche Dermatologique du Quebec Metropolitan
FG000428 subjects429 completed Part A. Subsequently, one subject discontinued so only 428 entered Part B
FG001208 subjects
COMPLETED
FG000353 subjects
FG001159 subjects
NOT COMPLETED
FG00075 subjects
FG00149 subjects
Type
Comment
Reasons
Pregnancy
FG0002 subjects
FG0010 subjects
Lack of Efficacy
FG0001 subjects
FG001
Part C Safety Follow up (4 Weeks)
Type
Comment
Milestone Data
STARTED
FG000353 subjects
FG001159 subjects
COMPLETED
FG000353 subjects
FG001159 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
ITT population
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
CD5024 1% Cream
Part A: CD5024 1% Cream, once daily application for 12 weeks
Part B: CD5024 1% Cream, once daily application for 40 weeks
BG001
CD5024 Vehicle Cream/Azelaic Acid 15% Gel
Part A: CD5024 Vehicle Cream, once daily application for 12 weeks
Part B: Azelaic acid 15% Gel, twice daily application for 40 weeks
BG002
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000459
BG001229
BG002688
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Year
Title
Denominators
Categories
Title
Measurements
BG00050.5± 12.35
BG00149.5± 12.16
BG00250.2± 12.29
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000314
BG001145
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00056
BG00131
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Skin Photo Type
DEFINITION OF SKIN PHOTOTYPE (T.B. Fitzpatrick):
I: Always burns easily ; never tans II: Always burns easily ; tans minimally and with difficulty III: Burns minimally ; tans gradually and uniformly (light Brown) IV: Burns minimally ; always tans well (moderate brown) V: Rarely burns ; tans profusely (dark brown)) VI:Never burns ; deeply pigmented (black), tans profusely
Number
Participants
Title
Denominators
Categories
I
Title
Measurements
BG00048
BG001
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
Success Rate
Percentage of subjects who achieve "Clear" (Score 0) or "Almost Clear" (Score 1) at Week 12 (ITT-LOCF) based on the Investigator Global Assessment (IGA) Score.
Evaluation of papulopustular rosacea will be performed by the investigator based on the following 5 point scale:
Clear = 0 (No inflammatory lesions present, no erythema); Almost Clear = 1 (Very few small papules/pustules, very mild erythema present); Mild = 2 (Few small papules/pustules, mild erythema); Moderate = 3 (Several small or large papules/pustules, moderate erythema); Severe = 4 (Numerous small and/or large papules/pustules, severe erythema)
LOCF, ITT
Posted
Number
Percentage of participants
Week 12
ID
Title
Description
OG000
CD5024 1% Cream
CD5024 1% Cream, once daily application for 12 weeks
OG001
CD5024 Vehicle Cream
CD5024 Vehicle Cream, once daily application for 12 weeks
Units
Counts
Participants
OG000459
OG001229
Title
Denominators
Categories
Title
Measurements
OG00040.1
OG00118.8
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Cochran-Mantel-Haenszel
<0.001
2-Sided
Superiority or Other (legacy)
Primary
Absolute Change in Inflammatory Lesion Count
Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).
LOCF, ITT
Posted
Mean
Standard Deviation
Lesion count change
Baseline to Week 12
ID
Title
Description
OG000
CD5024 1% Cream
CD5024 1% Cream, once daily application for 12 weeks
OG001
CD5024 Vehicle Cream
CD5024 Vehicle Cream, once daily application for 12 weeks
Units
Counts
Participants
OG000
Secondary
Percent Change in Inflammatory Lesion Count From Baseline to Week 12 (ITT-LOCF)
Inflammatory lesion counts were conducted at each visit by the Investigator or study coordinator. Papules and pustules were counted separately on each of the five facial regions (forehead, chin, nose, right cheek, left cheek).
Posted
Mean
Standard Deviation
Percentage of change in lesion counts
Baseline to Week 12
ID
Title
Description
OG000
CD5024 1% Cream
CD5024 1% Cream, once daily application for 12 weeks
OG001
CD5024 Vehicle Cream
CD5024 Vehicle Cream, once daily application for 12 weeks
Units
Counts
Participants
OG000
Time Frame
Time of signed informed consent to study end (~ 58 wks). Treatment emergent adverse events - occurred on date of 1st use of medication or after, except those reported from Day 1 lab data as blood sample was to be drawn before the time of 1st dose.
Description
Number of participants at risk based on actual number of participants who received each intervention as randomized or due to dispensing errors (3 subjects).
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
CD5024 1% Cream - Part A
Part A: CD5024 1% Cream, once daily application for 12 weeks
7
458
33
458
EG001
CD5024 Vehicle Cream - Part A
Part A: CD5024 Vehicle Cream, once daily application for 12 weeks
4
230
26
230
EG002
CD5024 1% Cream - Part B
Part B CD5024 1% Cream, once daily application for 40 weeks
13
428
102
428
EG003
Azelaic Acid 15% Gel - Part B
Part B: Subjects in the CD5024 Vehicle Cream arm applied Azelaic Acid 15% Gel twice daily for 40 weeks
4
208
47
208
EG004
CD5024 1% Cream - Part C
Part C: 4 week safety follow up. No drug applications
0
353
4
353
EG005
CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Part C
Part C: 4 week safety follow up. No drug applications
1
159
3
159
EG006
CD5024 1% Cream - Overall
Overall number of subjects with adverse events for the entire duration of study
18
460
125
460
EG007
CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Overall
Overall number of subjects with adverse events for the entire duration of study
9
231
64
231
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial fibrillation
Cardiac disorders
MedDRA (12.0)
EG0001 affected458 at risk
EG0010 affected230 at risk
EG0021 affected428 at risk
EG0030 affected208 at risk
EG0040 affected353 at risk
EG0050 affected159 at risk
EG0062 affected460 at risk
EG0070 affected231 at risk
Angina pectoris
Cardiac disorders
MedDRA (12.0)
EG0000 affected458 at risk
EG0010 affected230 at risk
EG0021 affected428 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA (12.0)
EG0001 affected458 at risk
EG0010 affected230 at risk
EG0020 affected428 at risk
EG003
Sick sinus syndrome
Cardiac disorders
MedDRA (12.0)
EG0000 affected458 at risk
EG0010 affected230 at risk
EG0021 affected428 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA (12.0)
EG0000 affected458 at risk
EG0010 affected230 at risk
EG0021 affected428 at risk
EG003
Aortic valve stenosis
Cardiac disorders
MedDRA (12.0)
EG0000 affected458 at risk
EG0010 affected230 at risk
EG0020 affected428 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (12.0)
EG0000 affected458 at risk
EG0010 affected230 at risk
EG0021 affected428 at risk
EG003
Oesophageal adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (12.0)
EG0000 affected458 at risk
EG0010 affected230 at risk
EG0021 affected428 at risk
EG003
B-cell lymphoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (12.0)
EG0001 affected458 at risk
EG0010 affected230 at risk
EG0020 affected428 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (12.0)
EG0000 affected458 at risk
EG0011 affected230 at risk
EG0020 affected428 at risk
EG003
Colon adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (12.0)
EG0000 affected458 at risk
EG0011 affected230 at risk
EG0020 affected428 at risk
EG003
Depression
Psychiatric disorders
MedDRA (12.0)
EG0002 affected458 at risk
EG0010 affected230 at risk
EG0020 affected428 at risk
EG003
Alcohol withdrawal syndrome
Psychiatric disorders
MedDRA (12.0)
EG0000 affected458 at risk
EG0010 affected230 at risk
EG0021 affected428 at risk
EG003
Major depression
Psychiatric disorders
MedDRA (12.0)
EG0000 affected458 at risk
EG0011 affected230 at risk
EG0020 affected428 at risk
EG003
Cholecystis chronic
Hepatobiliary disorders
MedDRA (12.0)
EG0001 affected458 at risk
EG0010 affected230 at risk
EG0020 affected428 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA (12.0)
EG0000 affected458 at risk
EG0010 affected230 at risk
EG0021 affected428 at risk
EG003
Multiple sclerosis
Nervous system disorders
MedDRA (12.0)
EG0000 affected458 at risk
EG0010 affected230 at risk
EG0021 affected428 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA (12.0)
EG0000 affected458 at risk
EG0010 affected230 at risk
EG0021 affected428 at risk
EG003
Headache
Nervous system disorders
MedDRA (12.0)
EG0000 affected458 at risk
EG0010 affected230 at risk
EG0020 affected428 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA (12.0)
EG0000 affected458 at risk
EG0010 affected230 at risk
EG0020 affected428 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA (12.0)
EG0001 affected458 at risk
EG0010 affected230 at risk
EG0020 affected428 at risk
EG003
Colonic obstruction
Gastrointestinal disorders
MedDRA (12.0)
EG0000 affected458 at risk
EG0010 affected230 at risk
EG0021 affected428 at risk
EG003
Anaphylactic reaction
Immune system disorders
MedDRA (12.0)
EG0001 affected458 at risk
EG0010 affected230 at risk
EG0020 affected428 at risk
EG003
Pneumonia
Infections and infestations
MedDRA (12.0)
EG0001 affected458 at risk
EG0010 affected230 at risk
EG0020 affected428 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA (12.0)
EG0000 affected458 at risk
EG0010 affected230 at risk
EG0020 affected428 at risk
EG003
Forearm fracture
Injury, poisoning and procedural complications
MedDRA (12.0)
EG0000 affected458 at risk
EG0010 affected230 at risk
EG0021 affected428 at risk
EG003
Postoperative ileus
Injury, poisoning and procedural complications
MedDRA (12.0)
EG0000 affected458 at risk
EG0011 affected230 at risk
EG0020 affected428 at risk
EG003
Incisional hernia
Injury, poisoning and procedural complications
MedDRA (12.0)
EG0000 affected458 at risk
EG0010 affected230 at risk
EG0020 affected428 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA (12.0)
EG0000 affected458 at risk
EG0010 affected230 at risk
EG0021 affected428 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA (12.0)
EG0000 affected458 at risk
EG0010 affected230 at risk
EG0021 affected428 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA (12.0)
EG0000 affected458 at risk
EG0010 affected230 at risk
EG0021 affected428 at risk
EG003
Dysfunctional uterine bleeding
Reproductive system and breast disorders
MedDRA (12.0)
EG0000 affected458 at risk
EG0010 affected230 at risk
EG0021 affected428 at risk
EG003
Menorrhagia
Reproductive system and breast disorders
MedDRA (12.0)
EG0000 affected458 at risk
EG0011 affected230 at risk
EG0020 affected428 at risk
EG003
Chest discomfort
General disorders
MedDRA (12.0)
EG0000 affected458 at risk
EG0010 affected230 at risk
EG0020 affected428 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (12.0)
EG0000 affected458 at risk
EG0010 affected230 at risk
EG0020 affected428 at risk
EG003
Hypertension
Vascular disorders
MedDRA (12.0)
EG0000 affected458 at risk
EG0011 affected230 at risk
EG0020 affected428 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nasopharyngitis
Infections and infestations
MedDRA 12.0
Systematic Assessment
EG00010 affected458 at risk
EG0016 affected230 at risk
EG00243 affected428 at risk
EG00318 affected208 at risk
EG0041 affected353 at risk
EG0051 affected159 at risk
EG00652 affected460 at risk
EG00723 affected231 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 12.0
EG00012 affected458 at risk
EG0018 affected230 at risk
EG00240 affected428 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 12.0
EG0009 affected458 at risk
EG0016 affected230 at risk
EG00220 affected428 at risk
EG003
Skin irritation
Skin and subcutaneous tissue disorders
MedDRA 12.0
EG0003 affected458 at risk
EG0017 affected230 at risk
EG0024 affected428 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
At least sixty (60) days prior to submission for publication, presentation or use, the Institution and the Investigator shall submit in writing to the Contract Research Organization and Sponsor for review and comment any proposed oral or written publication, which period may be extended for an additional thirty (30) days if requested in writing by Contract Research Organization and Sponsor.