Phase 3 Papulopustular Rosacea Study | NCT01493687 | Trialant
NCT01493687
Sponsor
Galderma R&D
Status
Completed
Last Update Posted
Feb 18, 2021Actual
Enrollment
683Actual
Phase
Phase 3
Conditions
Papulopustular Rosacea (PPR)
Interventions
CD5024
Azelaic acid 15% Gel
Countries
United States
Canada
Protocol Section
Identification Module
NCT ID
NCT01493687
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
RD.06.SPR.18170
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
Jul 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 16, 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 (PPR)
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
683Actual
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
UAB Dermatology Clinical Research
Birmingham
Alabama
35233
United States
Northwest AR Clinical Trials Center
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
Rogers
Arkansas
72758
United States
Dermatology Research Associates
Los Angeles
California
30127
United States
University Clinical Trials
San Diego
California
92123
United States
Research Across America
Santa Ana
California
92705
United States
Cherry Creek Research, Inc.
Denver
Colorado
80209
United States
The Center for Clinical & Cosmetic Research
Aventura
Florida
33180
United States
The Dermatology and Aesthetic Center
Boca Raton
Florida
33486
United States
North Florida Dermatology Associates
Jacksonville
Florida
32204
United States
FXM Research Miramar
Miramar
Florida
33027
United States
MedaPhase, Inc.
Newnan
Georgia
30263
United States
Laser & Skin Surgery Center of Indiana
Carmel
Indiana
46032
United States
The Indiana Clinical Trials Center
Plainfield
Indiana
46168
United States
The South Bend Clinic, LLP
South Bend
Indiana
46617
United States
Derm Research, PLLC
Louisville
Kentucky
40217
United States
Lawrence Green, MD, LLC
Rockville
Maryland
20850
United States
Henry Ford Health Systems Department of Dermatology
Detroit
Michigan
48202
United States
Grekin Skin Institute
Warren
Michigan
48088
United States
Central Dermatology PC
St Louis
Missouri
63117
United States
Skin Specialists, PC
Omaha
Nebraska
68144
United States
Anderson & Collins Clinical Research,
Edison
New Jersey
08817
United States
PMG Research of Charlotte
Charlotte
North Carolina
28277
United States
Wake Research Associates
Raleigh
North Carolina
27612
United States
Department of Dermatology - Wake Forest University Health Sciences
Winston-Salem
North Carolina
27157
United States
Dermatology Research Center of Cincinnati
Cincinnati
Ohio
45220
United States
Haber Dermatology Clinical Research Center
South Euclid
Ohio
44118
United States
Central Sooner Research
Norman
Oklahoma
73071
United States
Baker Allergy, Asthma and Dermatology Research Center
Lake Oswego
Oregon
97035
United States
PMG Research of Charleston
Mt. Pleasant
South Carolina
29464
United States
Palmetto Clinical Trial Services, LLC
Simpsonville
South Carolina
29681
United States
TriCities Skin and Cancer
Johnson City
Tennessee
37604
United States
Dermatology Associates of Kingsport, PC
Kingsport
Tennessee
37660
United States
DermResearch, Inc.
Austin
Texas
78759
United States
Modern Research Associates
Dallas
Texas
75231
United States
Center for Clinical Studies
Houston
Texas
77030
United States
Progressive Clinical Research
San Antonio
Texas
78229
United States
Dermatology Research Center, Inc.
Salt Lake City
Utah
84117
United States
The Education & Research Foundation, Inc.
Lynchburg
Virginia
24501
United States
PLLC dba Dermatology Associates
Seattle
Washington
98101
United States
The Polyclinic
Seattle
Washington
98122
United States
Stratica Medical Inc
Edmonton
Alberta
T5K 1X3
Canada
Derm Research@888 Inc.
Vancouver
British Columbia
V5Z 3Y1
Canada
Dermadvances Research
Winnepeg
Manitoba
R3C 1R4
Canada
Nexus Clinical Research
St. John's
Newfoundland and Labrador
A1A 5E8
Canada
Eastern Canada Cutaneous Research Associates
Halifax
Nova Scotia
B3H 1Z4
Canada
Skin Centre for Dermatology
Peterborough
Ontario
K9J 1Z2
Canada
Toronto Research Centre, Inc.
Toronto
Ontario
M3H 5Y8
Canada
Windsor Clinical Research, Inc.
Windsor
Ontario
N8W 5L7
Canada
Innovaderm Research. Inc
Montreal
Quebec
H2K 4L5
Canada
Siena Medical
Montreal
Quebec
H3Z 2S6
Canada
FG000451 subjects
FG001232 subjects
COMPLETED
FG000414 subjects
FG001210 subjects
NOT COMPLETED
FG00037 subjects
FG00122 subjects
Type
Comment
Reasons
Pregnancy
FG0002 subjects
FG0010 subjects
Lack of Efficacy
FG0000 subjects
FG0011 subjects
Adverse Event
FG0007 subjects
FG0014 subjects
Withdrawal by Subject
FG00018 subjects
FG0017 subjects
Protocol Violation
FG0002 subjects
FG0011 subjects
Lost to Follow-up
FG0007 subjects
FG0018 subjects
Other (noted on CRF)
FG0001 subjects
FG0011 subjects
Part B Long Term Active Control 40 Weeks
Type
Comment
Milestone Data
STARTED
FG000412 subjects414 completed Part A. Then 2 discontinued (lack of efficacy, subject request) prior to Part B.
FG001210 subjects
COMPLETED
FG000351 subjects
FG001175 subjects
NOT COMPLETED
FG00061 subjects
FG00135 subjects
Type
Comment
Reasons
Pregnancy
FG0005 subjects
FG0011 subjects
Lack of Efficacy
FG0002 subjects
FG001
Part C Safety Follow up (4 Weeks)
Type
Comment
Milestone Data
STARTED
FG000350 subjects351 completed Part B. Then 1 discontinued (subject request) prior to Part C.
FG001175 subjects
COMPLETED
FG000350 subjects
FG001174 subjects
NOT COMPLETED
FG0000 subjects
FG0011 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 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
BG000451
BG001232
BG002683
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
Years
Title
Denominators
Categories
Title
Measurements
BG00049.9± 12.15
BG00151.6± 11.92
BG00250.4± 12.09
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000314
BG001152
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00055
BG00123
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
BG00039
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: 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
OG000451
OG001232
Title
Denominators
Categories
Title
Measurements
OG00038.4
OG00111.6
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: 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).
LOCF, ITT
Posted
Mean
Standard Deviation
Percentage of change in lesion counts
Baseline to Week 12
ID
Title
Description
OG000
CD5024 1% Cream
CD5024: 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
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
CD5024 1% Cream - Part A
Part A: CD5024 1% Cream, once daily application for 12 weeks
3
452
30
452
EG001
CD5024 Vehicle Cream - Part A
Part A: CD5024 Vehicle Cream, once daily application for 12 weeks
1
231
10
231
EG002
CD5024 1% Cream - Part B
Part B CD5024 1% Cream, once daily application for 40 weeks
7
412
93
412
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
8
210
47
210
EG004
CD5024 1% Cream - Part C
Part C: 4 week safety follow up. No drug applications
0
350
4
350
EG005
CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Part C
Part C: 4 week safety follow up. No drug applications
1
175
0
175
EG006
CD5024 1% Cream - Overall
Overall number of subjects with adverse events for the entire duration of study
10
452
110
452
EG007
CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Overall
Overall number of subjects with adverse events for the entire duration of study
9
232
52
232
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cholelithiasis
Hepatobiliary disorders
MedDRA (12.0)
EG0000 affected452 at risk
EG0010 affected231 at risk
EG0021 affected412 at risk
EG0030 affected210 at risk
EG0040 affected350 at risk
EG0050 affected175 at risk
EG0061 affected452 at risk
EG0070 affected232 at risk
Cholecystitis
Hepatobiliary disorders
MedDRA (12.0)
EG0001 affected452 at risk
EG0010 affected231 at risk
EG0020 affected412 at risk
EG003
Transitional cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (12.0)
EG0000 affected452 at risk
EG0010 affected231 at risk
EG0021 affected412 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (12.0)
EG0000 affected452 at risk
EG0010 affected231 at risk
EG0021 affected412 at risk
EG003
Squamous cell carcinoma of skin
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (12.0)
EG0000 affected452 at risk
EG0010 affected231 at risk
EG0021 affected412 at risk
EG003
Pancreatic carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (12.0)
EG0000 affected452 at risk
EG0010 affected231 at risk
EG0020 affected412 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (12.0)
EG0000 affected452 at risk
EG0010 affected231 at risk
EG0020 affected412 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA (12.0)
EG0000 affected452 at risk
EG0010 affected231 at risk
EG0020 affected412 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA (12.0)
EG0000 affected452 at risk
EG0010 affected231 at risk
EG0021 affected412 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA (12.0)
EG0000 affected452 at risk
EG0010 affected231 at risk
EG0021 affected412 at risk
EG003
Atrioventricular block complete
Cardiac disorders
MedDRA (12.0)
EG0000 affected452 at risk
EG0010 affected231 at risk
EG0021 affected412 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA (12.0)
EG0000 affected452 at risk
EG0010 affected231 at risk
EG0020 affected412 at risk
EG003
Oesophageal ulcer perforation
Gastrointestinal disorders
MedDRA (12.0)
EG0000 affected452 at risk
EG0010 affected231 at risk
EG0021 affected412 at risk
EG003
Ascites
Gastrointestinal disorders
MedDRA (12.0)
EG0000 affected452 at risk
EG0010 affected231 at risk
EG0020 affected412 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA (12.0)
EG0000 affected452 at risk
EG0010 affected231 at risk
EG0021 affected412 at risk
EG003
Lobar pneumonia
Infections and infestations
MedDRA (12.0)
EG0000 affected452 at risk
EG0010 affected231 at risk
EG0020 affected412 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA (12.0)
EG0000 affected452 at risk
EG0010 affected231 at risk
EG0021 affected412 at risk
EG003
Intra-uterine death
Pregnancy, puerperium and perinatal conditions
MedDRA (12.0)
EG0001 affected452 at risk
EG0010 affected231 at risk
EG0020 affected412 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA (12.0)
EG0000 affected452 at risk
EG0010 affected231 at risk
EG0021 affected412 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA (12.0)
EG0000 affected452 at risk
EG0010 affected231 at risk
EG0020 affected412 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA (12.0)
EG0001 affected452 at risk
EG0010 affected231 at risk
EG0020 affected412 at risk
EG003
Femoral arterial stenosis
Vascular disorders
MedDRA (12.0)
EG0000 affected452 at risk
EG0010 affected231 at risk
EG0021 affected412 at risk
EG003
Shock
Vascular disorders
MedDRA (12.0)
EG0000 affected452 at risk
EG0010 affected231 at risk
EG0020 affected412 at risk
EG003
Hypotension
Vascular disorders
MedDRA (12.0)
EG0000 affected452 at risk
EG0011 affected231 at risk
EG0020 affected412 at risk
EG003
Haemorrhagic anaemia
Vascular disorders
MedDRA (12.0)
EG0000 affected452 at risk
EG0011 affected231 at risk
EG0020 affected412 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA (12.0)
EG0000 affected452 at risk
EG0010 affected231 at risk
EG0020 affected412 at risk
EG003
Cardiogenic shock
Cardiac disorders
MedDRA (12.0)
EG0000 affected452 at risk
EG0010 affected231 at risk
EG0020 affected412 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA (12.0)
EG0000 affected452 at risk
EG0010 affected231 at risk
EG0020 affected412 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nasopharyngitis
Infections and infestations
MedDRA (12.0)
EG00012 affected452 at risk
EG0016 affected231 at risk
EG00254 affected412 at risk
EG00331 affected210 at risk
EG0041 affected350 at risk
EG0050 affected175 at risk
EG00663 affected452 at risk
EG00734 affected232 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA (12.0)
EG0006 affected452 at risk
EG0012 affected231 at risk
EG00231 affected412 at risk
EG003
Headache
Nervous system disorders
MedDRA (12.0)
EG00013 affected452 at risk
EG0014 affected231 at risk
EG00217 affected412 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.