Safety and Tolerability of Antiplaque Chewing Gum in a Gi... | NCT01877421 | Trialant
NCT01877421
Sponsor
U.S. Army Medical Research and Development Command
Status
Completed
Last Update Posted
Feb 13, 2020Actual
Enrollment
135Actual
Phase
Phase 1Phase 2
Conditions
Plaque
Gingivitis
Interventions
2 mg KSL-W
4 mg KSL-W
6 mg KSL-W
10 mg KSL-W
20 mg KSL-W
30 mg KSL-W
50 mg KSL-W
75 mg KSL-W
100 mg KSL-W
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
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
NCT01877421
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
S-11-14
Secondary IDs
Not provided
Brief Title
Safety and Tolerability of Antiplaque Chewing Gum in a Gingivitis Population
Official Title
A Double-Blind, Randomized, Controlled, Dose Escalation Clinical Trial of an Antiplaque Chewing Gum - Phase 1 Safety and Tolerability and Phase 2a Safety, Tolerability, and Proof of Concept in a Gingivitis Population
Acronym
APCG
Organization
U.S. Army Medical Research and Development CommandFED
Status Module
Record Verification Date
Feb 2020
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
Feb 25, 2014Actual
Primary Completion Date
Aug 25, 2015Actual
Completion Date
Mar 2016Actual
First Submitted Date
May 14, 2013
First Submission Date that Met QC Criteria
Jun 10, 2013
First Posted Date
Jun 13, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Jan 30, 2017
Results First Submitted that Met QC Criteria
Aug 9, 2017
Results First Posted Date
Sep 13, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Feb 11, 2020
Last Update Posted Date
Feb 13, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
U.S. Army Medical Research and Development CommandFED
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
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
This study is to assess the safety and tolerability of single doses and multiple doses in reducing plaque and gingivitis when delivered in a chewing gum formulation.
Detailed Description
This study is a Phase 1/2a placebo-controlled, double-blind, randomized, dose-escalation study to evaluate the safety and proof of concept of Antiplaque Chewing Gum. This is a 2-part trial with 9 dosing cohorts in Phase 1 and 7 dosing cohorts in Phase 2a. For both phases, the oral soft (OST) and oral hard tissues (OHT) will be examined. Changes from baseline, such as soft tissue erythema, ulceration and sloughing, will be noted and assessments will be made by the principal investigator as to whether they might be attributable to the antiplaque chewing gum.
In the Phase 2a portion of the study, the efficacy of the antiplaque chewing gum in reducing existing supragingival plaque and gingivitis will also be assessed. Plaque will be assessed using the Turesky Modification of the Quigley-Hein Plaque Index (PI, Turesky et al-1970) and gingivitis will be assessed using both the Modified Gingival Index (MGI, Lobene et al-1986) and the percent of bleeding sites on gentle probing (BOP) using the methods described in Ainamo and Bay-1975.
Conditions Module
Conditions
Plaque
Gingivitis
Keywords
Reducing plaque
Reducing gingivitis
safety
proof of concept
antiplaque chewing gum
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 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
135Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
2 mg KSL-W (Phase 1, 1a)
Experimental
one 2 mg KSL-W tablet at day 0 at Phase 1
Drug: 2 mg KSL-W
4 mg KSL-W (Phase 1, 2a; Phase 2a, 1b)
Experimental
one 4 mg KSL-W tablet on day 0 at both Phase 1 and Phase 2a. one 4 mg KSL-W tablet on days 1-6; two 4 mg KSL-W tablets on days 7-13 and days 14-20; and three 4 mg tablets at days 21-27 at Phase 2a.
Drug: 4 mg KSL-W
6 mg KSL-W (Phase 1, 3a; Phase 2a, 2b)
Experimental
One 6 mg KSL-W tablet on day 0 at both Phase 1 and Phase 2a. One 6 mg KSL-W tablet on days 1-6; two 6 mg KSL-W tablets on days 7-13 and days 14-20; and three 6 mg tablets at days 21-27 at Phase 2a.
Drug: 6 mg KSL-W
10 mg KSL-W (Phase 1, 4a; Phase 2a, 3b)
Experimental
One 10 mg KSL-W tablet on day 0 at both Phase 1 and Phase 2a. One 10 mg KSL-W tablet on days 1-6; two 10 mg KSL-W tablets on days 7-13 and days 14-20; and three 10 mg tablets at days 21-27 at Phase 2a.
Drug: 10 mg KSL-W
20 mg KSL-W (Phase 1, 5a; Phase 2a, 4b)
Experimental
One 20 mg KSL-W tablet on day 0 at both Phase 1 and Phase 2a. One 20 mg KSL-W tablet on days 1-6; two 20 mg KSL-W tablets on days 7-13 and days 14-20; and three 20 mg tablets at days 21-27 at Phase 2a.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
2 mg KSL-W
Drug
2 mg KSL-W (Phase 1, 1a)
Antiplaque Chewing Gum
4 mg KSL-W
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs)
Occurrence of local oral mucosal reactions, systemic reactions such as fever, nausea, headache, and changes in blood pressure, clinical laboratory measures of safety, and serious total body reactions will be assessed (AEs and SAEs)
Up to 28 days
Secondary Outcomes
Measure
Description
Time Frame
Proof of Concept of KSL-W in Reducing Plaque in Phase 2a
Data summarizes plaque index scores changes from baseline. Supragingival plaque will be assessed after the MGI and BOP assessments and following use of a disclosing solution on the facial (buccal) and lingual surfaces of a minimum of 16 scorable teeth according to the criteria of the Turesky modification of the Quigley-Hein Plaque Index.
Quigley-Hein Plaque Index Scores with Turesky Modifications:
0 No plaque
Separate flecks of plaque at the cervical margin of the tooth
A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth
A band of plaque wider than one mm but covering less than one-third of the crown of the tooth
Plaque covering at least one-third but less than two thirds of the crown of the tooth
Plaque covering two-thirds or more of the crown of the tooth
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Subjects must meet all of the following criteria to be included in the Phase 1 portion of the study:
Males and females between 18 and 64 years of age
A negative urine pregnancy test and willingness to use a reliable form of contraception for the duration of the study (females of childbearing potential only), with reliable contraception defined as:
Abstinence Oral contraceptive, either estrogen progesterone combined, or progesterone alone Injectable progesterone Implants of levonorgestrel Estrogenic vaginal ring Percutaneous contraceptive patches Intrauterine device or intrauterine system Double barrier method [condom or occlusive cap (diaphragm or cervical vault caps) plus spermicidal agent (foam, gel, film, cream, suppository)] Male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject
Good health, as determined by pertinent medical history, physical examination, vital signs, and clinical safety laboratory evaluations
A minimum of 16 natural teeth with 2 scorable surfaces (facial and lingual) per tooth Sufficient number of opposing posterior teeth to chew on both sides of the mouth as determined by the examining dentist Teeth that have gross caries, full crowns or extensive restorations on facial and/or lingual surfaces, orthodontic bands, and third molars are not included in the tooth count
Ability to comprehend and a willingness to sign an informed consent, which includes the Authorization for the Release of Health Information document
Willingness to comply with all study procedures
Phase 2a Inclusion Criteria
Subjects must meet all the criteria for the phase 1 portion of the study, and in addition must:
Have mild to moderate gingivitis and plaque MGI of 1.8 or greater (Ainamo and Bay-1975) PI of 1.95 or greater (Turesky et al-1970)
Willing to forgo any optional dental procedures during the study period, such as dental prophylaxis or teeth whitening
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded from the study:
Acute or chronic medical conditions, organ system disease, or medications that, in the principal investigator's opinion, would impair the subject's ability to participate
TMD
Self-reported use of tobacco products
Use of anticoagulant medications (eg clopidogrel)
Gross oral pathology, including widespread caries or chronic neglect, extensive restoration, pre-existing gross plaque or calculus, or soft or hard tissue tumor of the oral cavity
Orthodontic appliances or removable partial dentures that will compromise the ability of the potential subject to participate in the study
Periodontitis as indicated periodontal pockets greater than 4 millimeters on more than one site
Receipt of any investigational drug/test product within 30 days prior to study entry
Receipt of antibiotics within 30 days prior to study entry
Need for antibiotic prophylaxis prior to invasive dental procedures
Receipt of daily anti-inflammatory therapy [eg nonsteroidal anti-inflammatory drugs (NSAID), tumor necrosis factor (TNF) alpha blockers] within 30 days prior to study entry
Receipt of prescription antibacterial oral products (eg products containing chlorhexidine) within 30 days prior to study entry
Pregnant or breast-feeding female
Clinically significant abnormal laboratory tests as determined by the principal investigator
An employee of the study site directly involved with the study
Inability to comply with assigned treatment regimen
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
64 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Domenick T Zero, DDS, MS
Indiana University
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Indiana University School of Dentistry, Oral Health Research Institute
Ryan JB, Kirkwood BJ, Leung KP. Combined Phase 1/2a Initial Clinical Safety Trials and Proof-of-Concept Assessment of a Novel Antimicrobial Peptide KSL-W Anti-Plaque Chewing Gum. Clin Exp Dent Res. 2024 Dec;10(6):e943. doi: 10.1002/cre2.943.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Not provided
Recruitment Details
There were a total of 137 planned subjects (71 in Phase 1 and 66 in Phase 2) to participate in this study at the Oral Health Research Institute, Indiana University School of Dentistry. There were a total of 135 enrolled (71 in Phase 1 and 64 in Phase 2). Phase 1 and 2 are individual periods ran in parallel.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
2mg KSL-W
2mg KSL-W
FG001
2mg Placebo
2mg Placebo
FG002
4mg KSL-W
4mg KSL-W
FG003
4mg Placebo
4mg Placebo
FG004
6mg KSL-W
6mg KSL-W
FG005
6mg Placebo
6mg Placebo
FG006
10mg KSL-W
10mg KSL-W
FG007
10mg Placebo
10mg Placebo
FG008
20mg KSL-W
20mg KSL-W
FG009
20mg Placebo
20mg Placebo
FG010
30mg KSL-W
30mg KSL-W
FG011
30mg Placebo
30mg Placebo
FG012
50mg KSL-W
50mg KSL-W
FG013
50mg Placebo
50mg Placebo
FG014
75mg KSL-W
75mg KSL-W
FG015
75mg Placebo
75mg Placebo
FG016
100mg KSL-W
100mg KSL-W
FG017
100mg Placebo
100mg Placebo
Periods
Title
Milestones
Reasons Not Completed
Phase 1
Type
Comment
Milestone Data
STARTED
FG0002 subjects
FG0011 subjects
FG0024 subjects
FG0032 subjects
FG0044 subjects
FG0052 subjects
FG0064 subjects
FG0072 subjects
FG0087 subjects
FG0093 subjects
FG0107 subjects
FG0113 subjects
FG0127 subjects
FG0133 subjects
FG0147 subjects
FG0153 subjects
FG0167 subjects
FG0173 subjects
COMPLETED
FG0002 subjects
FG0011 subjects
FG0024 subjects
FG0032 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Phase 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Phase 1, 1a (2mg)
Subjects from phase 1, 1a (2mg) group
BG001
Phase 1, 1a Placebo
Subjects from phase 1, 1a placebo group
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
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
Safety and Tolerability of KSL-W as Measured by Soft Tissue Erythema, Ulceration and Sloughing (AEs and SAEs)
Occurrence of local oral mucosal reactions, systemic reactions such as fever, nausea, headache, and changes in blood pressure, clinical laboratory measures of safety, and serious total body reactions will be assessed (AEs and SAEs)
Posted
Count of Participants
Participants
Up to 28 days
ID
Title
Description
OG000
Phase 1, 1a (2mg)
Subjects from phase 1, 1a (2mg) group
OG001
Phase 1, 1a Placebo
Subjects from phase 1, 1a placebo group
OG002
Adverse Events Module
Frequency Threshold
0
Time Frame
up to 28 days
Description
Formal statistical analysis of the safety data was not performed due to the small sample size.
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
Phase 1, 1a (2mg)
Subjects from phase 1, 1a (2mg) group
0
Serious Adverse Events
Not provided
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal discomfort
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
More Info Module
Limitations and Caveats
Not provided
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
Point of Contact
Title
Organization
Phone
Extension
Email
Domenick T. Zero, DDS, MS
Oral Health Research Institute, Indiana University School of Dentistry
240-457-0668
dzero@iu.edu
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
ID
Term
D058225
Plaque, Amyloid
D005891
Gingivitis
Ancestor Terms
ID
Term
D020763
Pathological Conditions, Anatomical
D013568
Pathological Conditions, Signs and Symptoms
D007239
Infections
D005882
Gingival Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel 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
Drug: 20 mg KSL-W
30 mg KSL-W (Phase 1, 6a; Phase 2a, 5b)
Experimental
One 30 mg KSL-W tablet on day 0 at both Phase 1 and Phase 2a. One 30 mg KSL-W tablet on days 1-6; two 30 mg KSL-W tablets on days 7-13 and days 14-20; and three 30 mg tablets at days 21-27 at Phase 2a.
Drug: 30 mg KSL-W
50 mg KSL-W (Phase 1, 7a; Phase 2a, 6b)
Experimental
One 50 mg KSL-W tablet on day 0 at both Phase 1 and Phase 2a. One 50 mg KSL-W tablet on days 1-6; two 50 mg KSL-W tablets on days 7-13 and days 14-20; and three 50 mg tablets at days 21-27 at Phase 2a.
Drug: 50 mg KSL-W
75 mg KSL-W (Phase 1, 8a; Phase 2a, 7b)
Experimental
One 75 mg KSL-W tablet on day 0 at both Phase 1 and Phase 2a. One 75 mg KSL-W tablet on days 1-6; two 75 mg KSL-W tablets on days 7-13 and days 14-20; and three 75 mg tablets at days 21-27 at Phase 2a.
Drug: 75 mg KSL-W
100 mg KSL-W (Phase 1, 9a)
Experimental
one 100 mg KSL-W tablet at day 0 at Phase 1
Drug: 100 mg KSL-W
Placebo
Placebo Comparator
Placebo
Other: Placebo
Drug
4 mg KSL-W (Phase 1, 2a; Phase 2a, 1b)
Antiplaque Chewing Gum
6 mg KSL-W
Drug
6 mg KSL-W (Phase 1, 3a; Phase 2a, 2b)
Antiplaque Chewing Gum
10 mg KSL-W
Drug
10 mg KSL-W (Phase 1, 4a; Phase 2a, 3b)
Antiplaque Chewing Gum
20 mg KSL-W
Drug
20 mg KSL-W (Phase 1, 5a; Phase 2a, 4b)
Antiplaque Chewing Gum
30 mg KSL-W
Drug
30 mg KSL-W (Phase 1, 6a; Phase 2a, 5b)
Antiplaque Chewing Gum
50 mg KSL-W
Drug
50 mg KSL-W (Phase 1, 7a; Phase 2a, 6b)
Antiplaque Chewing Gum
75 mg KSL-W
Drug
75 mg KSL-W (Phase 1, 8a; Phase 2a, 7b)
Antiplaque Chewing Gum
100 mg KSL-W
Drug
100 mg KSL-W (Phase 1, 9a)
Antiplaque Chewing Gum
Placebo
Other
Cetylpyridinium chloride (CPC) as an additive, isomalt as a bulk sweetener, peppermint powder for flavoring, sucralose as an intense sweetener, colloidal silicon dioxide is a flow enhancer, magnesium stearate as a process aid, and the proprietary gum base formulation.
Placebo
days 14, 28, 34
Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a
Data summarizes gingival index scores changes from baseline in phase 2a. Gingivitis will be assessed using both the MGI (Modified Gingival Index) and the Gingival Bleeding Index (BOP) The Modified Gingival Index assesses the buccal and lingual gingivae and interdental papillae.
Modified Gingival Index Scores:
0 Absence of inflammation
Mild inflammation; slight change in color, little change in texture of any portion of but not the entire marginal or papillary gingival unit
Mild inflammation; criteria as above but involving the entire marginal or papillary gingival unit
Moderate inflammation; glazing, redness, edema and/or hypertrophy of the marginal or papillary gingival unit
Severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration.
days 14, 28, 34
Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a
Proof of concept of KSL-W in reducing plaque as measured by percent of bleeding sites upon probing (BOP) in phase 2a.
Gingivitis will be assessed using both the MGI (Modified Gingival Index) and the Gingival Bleeding Index (BOP). The Modified Gingival Index assesses the buccal and lingual gingivae and interdental papillae. The Gingival Bleeding Index assesses the percentage of sites that bleed on gentle probing. A periodontal probe (HU-Friedy UNC 15) will be gently inserted into the gingival sulcus until resistance is felt at mid-facial (buccal), mid-lingual, mesial, and distal interproximal sites of all scorable teeth, with the exception of the most posterior distal sites. Presence or absence of bleeding will be recorded for each site and the percentage of bleeding sites per subject will serve as the unit of analysis.
days 0, 14, 28, 34
4 subjects
FG0052 subjects
FG0064 subjects
FG0072 subjects
FG0087 subjects
FG0093 subjects
FG0107 subjects
FG0113 subjects
FG0127 subjects
FG0133 subjects
FG0147 subjects
FG0153 subjects
FG0167 subjects
FG0173 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
2 subjects
FG0047 subjects
FG0053 subjects
FG0067 subjects
FG0072 subjects
FG0086 subjects
FG0093 subjects
FG0107 subjects
FG0113 subjects
FG0127 subjects
FG0133 subjects
FG0147 subjects
FG0153 subjects
FG0160 subjects
FG0170 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0024 subjects
FG0032 subjects
FG0047 subjects
FG0053 subjects
FG0066 subjects
FG0072 subjects
FG0085 subjects
FG0093 subjects
FG0105 subjects
FG0113 subjects
FG0126 subjects
FG0133 subjects
FG0147 subjects
FG0152 subjects
FG0160 subjects
FG0170 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0102 subjects
FG0110 subjects
FG0121 subjects
FG0130 subjects
FG0140 subjects
FG0151 subjects
FG0160 subjects
FG0170 subjects
Type
Comment
Reasons
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
FG0140 subjects
FG0150 subjects
FG0160 subjects
FG0170 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
BG002
Phase 1, 2a (4mg)
Subjects from phase 1, 2a (4mg) group
BG003
Phase 1, 2a Placebo
Subjects from phase 1, 2a (4mg) group
BG004
Phase 1, 3a (6mg)
Subject from phase 1, 3a (6mg) group
BG005
Phase 1, 3a Placebo
Subjects from phase 1, 3a placebo gorup
BG006
Phase 1, 4a (10mg)
Subjects from phase 1, 4a (10mg) group
BG007
Phase 1, 4a Placebo
Subjects from phase 1, 4a placebo group
BG008
Phase 1, 5a (20mg)
Subjects from phase 1, 5a (20mg) group
BG009
Phase 1, 5a Placebo
Subjects from phase1, 5a placebo group
BG010
Phase 1, 6a (30mg)
Subjects from phase 1, 6a (30mg) group
BG011
Phase 1, 6a Placebo
Subjects from phase 1, 6a placebo group
BG012
Phase 1, 7a (50mg)
Subjects from phase 1, 7a (50mg) group
BG013
Phase 1, 7a Placebo
Subjects from phase 1, 7a placebo group
BG014
Phase 1, 8a (75mg)
Subjects from phase 1, 8a (75mg) group
BG015
Phase 1, 8a Placebo
Subjects from phase 1, 8a placebo group
BG016
Phase 1, 9a (100mg)
Subjects from phase 1, 9a (100mg) group
BG017
Phase 1, 9a Placebo
Subjects from phase 1, 9a placebo group
BG018
Phase 2, 1b (4mg)
Subjects from phase 2, 1b (4mg) group
BG019
Phase 2, 1b Placebo
Subjects from phase 2, 1b placebo
BG020
Phase 2, 2b (6mg)
Subjects from phase 2, 2b (6mg) group
BG021
Phase 2, 2b Placebo
Subjects from phase 2, 2b placebo group
BG022
Phase 2, 3b (10mg)
Subjects from phase 2, 3b (10mg) group
BG023
Phase 2, 3b Placebo
Subjects from phase 2, 3b placebo group
BG024
Phase 2, 4b (20mg)
Subjects from phase 2, 4b (20mg) group
BG025
Phase 2, 4b Placebo
Subjects from phase 2, 4b placebo group
BG026
Phase 2, 5b (30mg)
Subjects from phase 2, 5b (30mg) group
BG027
Phase 2, 5b Placebo
Subjects from phase 2, 5b placebo group
BG028
Phase 2, 6b (50mg)
Subjects from phase 2, 6b (50mg) group
BG029
Phase 2, 6b Placebo
Subjects from phase 2, 6b placebo group
BG030
Phase 2, 7b (75mg)
Subjects from phase 2, 7b (75mg) group
BG031
Phase 2, 7b Placebo
Subjects from phase 2, 7b placebo group
BG032
Total
Total of all reporting groups
2
BG0011
BG0024
BG0032
BG0044
BG0052
BG0064
BG0072
BG0087
BG0093
BG0107
BG0113
BG0127
BG0133
BG0147
BG0153
BG0167
BG0173
BG0184
BG0192
BG0207
BG0213
BG0227
BG0232
BG0246
BG0253
BG0267
BG0273
BG0287
BG0293
BG0307
BG0313
BG032135
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00045.5± 0.7
BG00149.0± NASD not derived because n=1
BG00231.8± 5.5
BG00341.5± 2.1
BG00429.8± 5.1
BG00540.0± 5.7
BG00644.5± 5.0
BG00744.0± 11.3
BG00838.0± 14.3
BG00949.7± 9.5
BG01036.7± 8.9
BG01136.0± 5.6
BG01227.4± 7.5
BG01335.0± 19.1
BG01429.3± 6.7
BG01544.7± 13.6
BG01626.4± 10.4
BG01733.7± 20.6
BG01831.5± 11.4
BG01936.5± 16.3
BG02038.1± 12.2
BG02122.0± 3.6
BG02225.7± 5.8
BG02333.0± 15.6
BG02430.2± 14.3
BG02534.3± 13.6
BG02621.3± 4.8
BG02724.0± 5.0
BG02837.3± 13.9
BG02926.0± 10.4
BG03026.0± 5.0
BG03121.7± 0.6
BG03221.3± 0
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0011
BG0023
BG0031
BG0042
BG0050
BG0060
BG0071
BG0084
BG0091
BG0105
BG0113
BG0126
BG0133
BG0145
BG0153
BG0165
BG0172
BG0181
BG0190
BG0205
BG0211
BG0221
BG0231
BG0243
BG0251
BG0262
BG0272
BG0285
BG0292
BG0303
BG0312
BG03276
Male
BG0000
BG0010
BG0021
BG0031
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG0020
BG0030
BG0041
BG0050
BG0060
BG0070
BG0084
BG0090
BG0101
BG0110
BG0120
BG0130
BG0140
BG0151
BG0163
BG0171
BG0181
BG0190
BG0200
BG0210
BG0220
BG0230
BG0240
BG0250
BG0260
BG0270
BG0280
BG0290
BG0301
BG0310
BG03213
Not Hispanic or Latino
BG0002
BG0011
BG0024
BG0032
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
BG0100
BG0110
BG0120
BG0130
BG0140
BG0150
BG0160
BG0170
BG0180
BG0190
BG0200
BG0210
BG0220
BG0230
BG0240
BG0250
BG0260
BG0270
BG0280
BG0290
BG0300
BG0310
BG0320
Asian
BG0000
BG0010
BG0021
BG0030
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0002
BG0010
BG0020
BG0030
BG004
White
BG0000
BG0011
BG0023
BG0032
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0002
BG0011
BG0024
BG0032
BG0044
BG0052
BG0064
BG0072
BG0087
BG0093
BG0107
BG0113
BG0127
BG0133
BG0147
BG0153
BG0167
BG0173
BG0184
BG0192
BG0207
BG0213
BG0227
BG0232
BG0246
BG0253
BG0267
BG0273
BG0287
BG0293
BG0307
BG0313
BG032135
Phase 1, 2a (4mg)
Subjects from phase 1, 2a (4mg) group
OG003
Phase 1, 2a Placebo
Subjects from phase 1, 2a (4mg) group
OG004
Phase 1, 3a (6mg)
Subject from phase 1, 3a (6mg) group
OG005
Phase 1, 3a Placebo
Subjects from phase 1, 3a placebo gorup
OG006
Phase 1, 4a (10mg)
Subjects from phase 1, 4a (10mg) group
OG007
Phase 1, 4a Placebo
Subjects from phase 1, 4a placebo group
OG008
Phase 1, 5a (20mg)
Subjects from phase 1, 5a (20mg) group
OG009
Phase 1, 5a Placebo
Subjects from phase1, 5a placebo group
OG010
Phase 1, 6a (30mg)
Subjects from phase 1, 6a (30mg) group
OG011
Phase 1, 6a Placebo
Subjects from phase 1, 6a placebo group
OG012
Phase 1, 7a (50mg)
Subjects from phase 1, 7a (50mg) group
OG013
Phase 1, 7a Placebo
Subjects from phase 1, 7a placebo group
OG014
Phase 1, 8a (75mg)
Subjects from phase 1, 8a (75mg) group
OG015
Phase 1, 8a Placebo
Subjects from phase 1, 8a placebo group
OG016
Phase 1, 9a (100mg)
Subjects from phase 1, 9a (100mg) group
OG017
Phase 1, 9a Placebo
Subjects from phase 1, 9a placebo group
OG018
Phase 2, 1b (4mg)
Subjects from phase 2, 1b (4mg) group
OG019
Phase 2, 1b Placebo
Subjects from phase 2, 1b placebo
OG020
Phase 2, 2b (6mg)
Subjects from phase 2, 2b (6mg) group
OG021
Phase 2, 2b Placebo
Subjects from phase 2, 2b placebo group
OG022
Phase 2, 3b (10mg)
Subjects from phase 2, 3b (10mg) group
OG023
Phase 2, 3b Placebo
Subjects from phase 2, 3b placebo group
OG024
Phase 2, 4b (20mg)
Subjects from phase 2, 4b (20mg) group
OG025
Phase 2, 4b Placebo
Subjects from phase 2, 4b placebo group
OG026
Phase 2, 5b (30mg)
Subjects from phase 2, 5b (30mg) group
OG027
Phase 2, 5b Placebo
Subjects from phase 2, 5b placebo group
OG028
Phase 2, 6b (50mg)
Subjects from phase 2, 6b (50mg) group
OG029
Phase 2, 6b Placebo
Subjects from phase 2, 6b placebo group
OG030
Phase 2, 7b (75mg)
Subjects from phase 2, 7b (75mg) group
OG031
Phase 2, 7b Placebo
Subjects from phase 2, 7b placebo group
Units
Counts
Participants
OG0002
OG0011
OG0024
OG0032
OG0044
OG0052
OG0064
OG0072
OG0087
OG0093
OG0107
OG0113
OG0127
OG0133
OG0147
OG0153
OG0167
OG0173
OG0184
OG0192
OG0207
OG0213
OG0227
OG0232
OG0246
OG0253
OG0267
OG0273
OG0287
OG0293
OG0307
OG0313
Title
Denominators
Categories
Title
Measurements
Subject Experiencing AEs = NO
OG0002
OG0011
OG0024
OG0032
OG0044
OG0051
OG0064
OG0071
OG0086
OG0091
OG0107
OG0113
OG0127
OG0133
OG0145
OG0153
OG0165
OG0173
OG0182
OG0191
OG0204
OG0212
OG0224
OG0232
OG0245
OG0251
OG0262
OG0271
OG0282
OG0292
OG0302
OG0313
Subjects Experiencing AEs = YES
OG0000
OG0010
OG0020
OG0030
OG004
Secondary
Proof of Concept of KSL-W in Reducing Plaque in Phase 2a
Data summarizes plaque index scores changes from baseline. Supragingival plaque will be assessed after the MGI and BOP assessments and following use of a disclosing solution on the facial (buccal) and lingual surfaces of a minimum of 16 scorable teeth according to the criteria of the Turesky modification of the Quigley-Hein Plaque Index.
Quigley-Hein Plaque Index Scores with Turesky Modifications:
0 No plaque
Separate flecks of plaque at the cervical margin of the tooth
A thin continuous band of plaque (up to one mm) at the cervical margin of the tooth
A band of plaque wider than one mm but covering less than one-third of the crown of the tooth
Plaque covering at least one-third but less than two thirds of the crown of the tooth
Plaque covering two-thirds or more of the crown of the tooth
Posted
Mean
Standard Deviation
scores on a scale
days 14, 28, 34
ID
Title
Description
OG000
Phase 2, 1b (4mg)
Subjects from phase 2, 1b (4mg) group
OG001
Phase 2, 1b Placebo
Subjects from phase 2, 1b placebo
OG002
Phase 2, 2b (6mg)
Subjects from phase 2, 2b (6mg) group
OG003
Phase 2, 2b Placebo
Subjects from phase 2, 2b placebo group
OG004
Phase 2, 3b (10mg)
Subjects from phase 2, 3b (10mg) group
OG005
Phase 2, 3b Placebo
Subjects from phase 2, 3b placebo group
OG006
Phase 2, 4b (20mg)
Subjects from phase 2, 4b (20mg) group
OG007
Phase 2, 4b Placebo
Subjects from phase 2, 4b placebo group
OG008
Phase 2, 5b (30mg)
Subjects from phase 2, 5b (30mg) group
OG009
Phase 2, 5b Placebo
Subjects from phase 2, 5b placebo group
OG010
Phase 2, 6b (50mg)
Subjects from phase 2, 6b (50mg) group
OG011
Phase 2, 6b Placebo
Subjects from phase 2, 6b placebo group
OG012
Phase 2, 7b (75mg)
Subjects from phase 2, 7b (75mg) group
OG013
Phase 2, 7b Placebo
Subjects from phase 2, 7b placebo group
Units
Counts
Participants
OG0004
OG0012
OG0027
OG003
Title
Denominators
Categories
Whole Mouth: Day 14
Title
Measurements
OG0000.20± 0.30
OG001-0.06± 0.02
OG002-0.12± 0.16
OG003
Secondary
Proof of Concept of KSL-W in Reducing Gingivitis in Phase 2a
Data summarizes gingival index scores changes from baseline in phase 2a. Gingivitis will be assessed using both the MGI (Modified Gingival Index) and the Gingival Bleeding Index (BOP) The Modified Gingival Index assesses the buccal and lingual gingivae and interdental papillae.
Modified Gingival Index Scores:
0 Absence of inflammation
Mild inflammation; slight change in color, little change in texture of any portion of but not the entire marginal or papillary gingival unit
Mild inflammation; criteria as above but involving the entire marginal or papillary gingival unit
Moderate inflammation; glazing, redness, edema and/or hypertrophy of the marginal or papillary gingival unit
Severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration.
Posted
Mean
Standard Deviation
scores on a scale
days 14, 28, 34
ID
Title
Description
OG000
Phase 2, 1b (4mg)
Subjects from phase 2, 1b (4mg) group
OG001
Phase 2, 1b Placebo
Subjects from phase 2, 1b placebo
OG002
Phase 2, 2b (6mg)
Subjects from phase 2, 2b (6mg) group
OG003
Phase 2, 2b Placebo
Subjects from phase 2, 2b placebo group
OG004
Phase 2, 3b (10mg)
Subjects from phase 2, 3b (10mg) group
OG005
Phase 2, 3b Placebo
Subjects from phase 2, 3b placebo group
OG006
Phase 2, 4b (20mg)
Subjects from phase 2, 4b (20mg) group
OG007
Phase 2, 4b Placebo
Subjects from phase 2, 4b placebo group
OG008
Phase 2, 5b (30mg)
Subjects from phase 2, 5b (30mg) group
OG009
Phase 2, 5b Placebo
Subjects from phase 2, 5b placebo group
OG010
Phase 2, 6b (50mg)
Subjects from phase 2, 6b (50mg) group
OG011
Phase 2, 6b Placebo
Subjects from phase 2, 6b placebo group
OG012
Phase 2, 7b (75mg)
Subjects from phase 2, 7b (75mg) group
OG013
Phase 2, 7b Placebo
Subjects from phase 2, 7b placebo group
Units
Counts
Participants
OG0004
OG0012
OG0027
OG003
Title
Denominators
Categories
Whole Mouth: Day 14
Title
Measurements
OG000-0.03± 0.05
OG001-0.06± 0.09
OG0020.00± 0.04
OG003
Secondary
Gingival Bleeding on Probing (BOP) - Percent of Bleeding Sites Upon Probing in Phase 2a
Proof of concept of KSL-W in reducing plaque as measured by percent of bleeding sites upon probing (BOP) in phase 2a.
Gingivitis will be assessed using both the MGI (Modified Gingival Index) and the Gingival Bleeding Index (BOP). The Modified Gingival Index assesses the buccal and lingual gingivae and interdental papillae. The Gingival Bleeding Index assesses the percentage of sites that bleed on gentle probing. A periodontal probe (HU-Friedy UNC 15) will be gently inserted into the gingival sulcus until resistance is felt at mid-facial (buccal), mid-lingual, mesial, and distal interproximal sites of all scorable teeth, with the exception of the most posterior distal sites. Presence or absence of bleeding will be recorded for each site and the percentage of bleeding sites per subject will serve as the unit of analysis.
Posted
Mean
Standard Deviation
Percent of bleeding sites
days 0, 14, 28, 34
ID
Title
Description
OG000
Phase 2, 1b (4mg)
Subjects from phase 2, 1b (4mg) group
OG001
Phase 2, 1b Placebo
Subjects from phase 2, 1b placebo
OG002
Phase 2, 2b (6mg)
Subjects from phase 2, 2b (6mg) group
OG003
Phase 2, 2b Placebo
Subjects from phase 2, 2b placebo group
OG004
Phase 2, 3b (10mg)
Subjects from phase 2, 3b (10mg) group
OG005
Phase 2, 3b Placebo
Subjects from phase 2, 3b placebo group
OG006
Phase 2, 4b (20mg)
Subjects from phase 2, 4b (20mg) group
OG007
Phase 2, 4b Placebo
Subjects from phase 2, 4b placebo group
OG008
Phase 2, 5b (30mg)
Subjects from phase 2, 5b (30mg) group
OG009
Phase 2, 5b Placebo
Subjects from phase 2, 5b placebo group
OG010
Phase 2, 6b (50mg)
Subjects from phase 2, 6b (50mg) group
OG011
Phase 2, 6b Placebo
Subjects from phase 2, 6b placebo group
OG012
Phase 2, 7b (75mg)
Subjects from phase 2, 7b (75mg) group
OG013
Phase 2, 7b Placebo
Subjects from phase 2, 7b placebo group
Units
Counts
Participants
OG0004
OG0012
OG0027
OG003
Title
Denominators
Categories
Whole Mouth: Eligibility
Title
Measurements
OG00016± 15
OG00127± 26
OG00226± 10
OG003
2
0
2
0
2
EG001
Phase 1, 1a Placebo
Subjects from phase 1, 1a placebo group
0
1
0
1
0
1
EG002
Phase 1, 2a (4mg)
Subjects from phase 1, 2a (4mg) group
0
4
0
4
0
4
EG003
Phase 1, 2a Placebo
Subjects from phase 1, 2a (4mg) group
0
2
0
2
0
2
EG004
Phase 1, 3a (6mg)
Subject from phase 1, 3a (6mg) group
0
4
0
4
0
4
EG005
Phase 1, 3a Placebo
Subjects from phase 1, 3a placebo gorup
0
2
0
2
1
2
EG006
Phase 1, 4a (10mg)
Subjects from phase 1, 4a (10mg) group
0
4
0
4
0
4
EG007
Phase 1, 4a Placebo
Subjects from phase 1, 4a placebo group
0
2
0
2
1
2
EG008
Phase 1, 5a (20mg)
Subjects from phase 1, 5a (20mg) group
0
7
0
7
1
7
EG009
Phase 1, 5a Placebo
Subjects from phase1, 5a placebo group
0
3
0
3
2
3
EG010
Phase 1, 6a (30mg)
Subjects from phase 1, 6a (30mg) group
0
7
0
7
0
7
EG011
Phase 1, 6a Placebo
Subjects from phase 1, 6a placebo group
0
3
0
3
0
3
EG012
Phase 1, 7a (50mg)
Subjects from phase 1, 7a (50mg) group
0
7
0
7
0
7
EG013
Phase 1, 7a Placebo
Subjects from phase 1, 7a placebo group
0
3
0
3
0
3
EG014
Phase 1, 8a (75mg)
Subjects from phase 1, 8a (75mg) group
0
7
0
7
2
7
EG015
Phase 1, 8a Placebo
Subjects from phase 1, 8a placebo group
0
3
0
3
0
3
EG016
Phase 1, 9a (100mg)
Subjects from phase 1, 9a (100mg) group
0
7
0
7
2
7
EG017
Phase 1, 9a Placebo
Subjects from phase 1, 9a placebo group
0
3
0
3
0
3
EG018
Phase 2, 1b (4mg)
Subjects from phase 2, 1b (4mg) group
0
4
0
4
2
4
EG019
Phase 2, 1b Placebo
Subjects from phase 2, 1b placebo
0
2
0
2
1
2
EG020
Phase 2, 2b (6mg)
Subjects from phase 2, 2b (6mg) group
0
7
0
7
3
7
EG021
Phase 2, 2b Placebo
Subjects from phase 2, 2b placebo group
0
3
0
3
1
3
EG022
Phase 2, 3b (10mg)
Subjects from phase 2, 3b (10mg) group
0
7
0
7
3
7
EG023
Phase 2, 3b Placebo
Subjects from phase 2, 3b placebo group
0
2
0
2
0
2
EG024
Phase 2, 4b (20mg)
Subjects from phase 2, 4b (20mg) group
0
7
0
6
1
6
EG025
Phase 2, 4b Placebo
Subjects from phase 2, 4b placebo group
0
3
0
3
2
3
EG026
Phase 2, 5b (30mg)
Subjects from phase 2, 5b (30mg) group
0
7
0
7
5
7
EG027
Phase 2, 5b Placebo
Subjects from phase 2, 5b placebo group
0
3
0
3
2
3
EG028
Phase 2, 6b (50mg)
Subjects from phase 2, 6b (50mg) group
0
7
0
7
5
7
EG029
Phase 2, 6b Placebo
Subjects from phase 2, 6b placebo group
0
3
0
3
1
3
EG030
Phase 2, 7b (75mg)
Subjects from phase 2, 7b (75mg) group
0
7
0
7
5
7
EG031
Phase 2, 7b Placebo
Subjects from phase 2, 7b placebo group
0
3
0
3
0
3
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0081 events1 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected2 at risk
EG0200 events0 affected7 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected7 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected7 at risk
EG0290 events0 affected3 at risk
EG0301 events1 affected7 at risk
EG0310 events0 affected3 at risk
Abdominal discomfort
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected2 at risk
EG0200 events0 affected7 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0251 events1 affected3 at risk
EG0260 events0 affected7 at risk
EG0271 events1 affected3 at risk
EG0280 events0 affected7 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected7 at risk
EG0310 events0 affected3 at risk
Ageusia
Nervous system disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected2 at risk
EG0200 events0 affected7 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected7 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected7 at risk
EG0290 events0 affected3 at risk
EG0301 events1 affected7 at risk
EG0310 events0 affected3 at risk
Arthropod bite
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected2 at risk
EG0200 events0 affected7 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected7 at risk
EG0270 events0 affected3 at risk
EG0281 events1 affected7 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected7 at risk
EG0310 events0 affected3 at risk
Aspartate aminotransferase increased
Investigations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0181 events1 affected4 at risk
EG0190 events0 affected2 at risk
EG0200 events0 affected7 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected7 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected7 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected7 at risk
EG0310 events0 affected3 at risk
Blood glucose increased
Investigations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0161 events1 affected7 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
EG0191 events1 affected2 at risk
EG0200 events0 affected7 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected7 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected7 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected7 at risk
EG0310 events0 affected3 at risk
Burning sensation in throat
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0141 events1 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected2 at risk
EG0200 events0 affected7 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected7 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected7 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected7 at risk
EG0310 events0 affected3 at risk
Glucose urine present
Renal and urinary disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0181 events1 affected4 at risk
EG0190 events0 affected2 at risk
EG0200 events0 affected7 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected7 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected7 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected7 at risk
EG0310 events0 affected3 at risk
Coating in mouth
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected2 at risk
EG0200 events0 affected7 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected7 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected7 at risk
EG0290 events0 affected3 at risk
EG0301 events1 affected7 at risk
EG0310 events0 affected3 at risk
Device connection issue
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected2 at risk
EG0200 events0 affected7 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0251 events1 affected3 at risk
EG0260 events0 affected7 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected7 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected7 at risk
EG0310 events0 affected3 at risk
Dysgeusia
Nervous system disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected2 at risk
EG0200 events0 affected7 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected7 at risk
EG0270 events0 affected3 at risk
EG0282 events2 affected7 at risk
EG0290 events0 affected3 at risk
EG0303 events3 affected7 at risk
EG0310 events0 affected3 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected2 at risk
EG0200 events0 affected7 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected7 at risk
EG0230 events0 affected2 at risk
EG0241 events1 affected6 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected7 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected7 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected7 at risk
EG0310 events0 affected3 at risk
Dyspepsia
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0141 events1 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected2 at risk
EG0200 events0 affected7 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected7 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected7 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected7 at risk
EG0310 events0 affected3 at risk
Ear infection
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected2 at risk
EG0201 events1 affected7 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected7 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected7 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected7 at risk
EG0310 events0 affected3 at risk
Erythema, hard palate, right side, molar area
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0091 events1 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected2 at risk
EG0200 events0 affected7 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected7 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected7 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected7 at risk
EG0310 events0 affected3 at risk
Flatulence
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected2 at risk
EG0201 events1 affected7 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected7 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected7 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected7 at risk
EG0310 events0 affected3 at risk
Food poisoning
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected2 at risk
EG0200 events0 affected7 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0250 events0 affected3 at risk
EG0261 events1 affected7 at risk
EG0270 events0 affected3 at risk
EG0281 events1 affected7 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected7 at risk
EG0310 events0 affected3 at risk
Abdomin discomfort, upper stomach
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected2 at risk
EG0200 events0 affected7 at risk
EG0210 events0 affected3 at risk
EG0221 events1 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected7 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected7 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected7 at risk
EG0310 events0 affected3 at risk
Gingival ulceration
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected2 at risk
EG0200 events0 affected7 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0250 events0 affected3 at risk
EG0261 events1 affected7 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected7 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected7 at risk
EG0310 events0 affected3 at risk
Headache
Nervous system disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0161 events1 affected7 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected2 at risk
EG0200 events0 affected7 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0250 events0 affected3 at risk
EG0261 events1 affected7 at risk
EG0271 events1 affected3 at risk
EG0280 events0 affected7 at risk
EG0291 events1 affected3 at risk
EG0300 events0 affected7 at risk
EG0310 events0 affected3 at risk
Mouth haemorrhage
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected2 at risk
EG0200 events0 affected7 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0250 events0 affected3 at risk
EG0261 events1 affected7 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected7 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected7 at risk
EG0310 events0 affected3 at risk
Mouth injury
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
EG0191 events1 affected2 at risk
EG0200 events0 affected7 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0250 events0 affected3 at risk
EG0261 events1 affected7 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected7 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected7 at risk
EG0310 events0 affected3 at risk
Mouth ulceration
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0051 events1 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
EG0191 events1 affected2 at risk
EG0200 events0 affected7 at risk
EG0210 events0 affected3 at risk
EG0221 events1 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected7 at risk
EG0271 events1 affected3 at risk
EG0280 events0 affected7 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected7 at risk
EG0310 events0 affected3 at risk
Muscle strain
Injury, poisoning and procedural complications
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0071 events1 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0181 events1 affected4 at risk
EG0190 events0 affected2 at risk
EG0200 events0 affected7 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected7 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected7 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected7 at risk
EG0310 events0 affected3 at risk
Nasopharyngitis
Infections and infestations
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected2 at risk
EG0201 events1 affected7 at risk
EG0211 events1 affected3 at risk
EG0221 events1 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected7 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected7 at risk
EG0290 events0 affected3 at risk
EG0303 events3 affected7 at risk
EG0310 events0 affected3 at risk
Oral mucosal erythema
Gastrointestinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected2 at risk
EG0200 events0 affected7 at risk
EG0210 events0 affected3 at risk
EG0221 events1 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0250 events0 affected3 at risk
EG0260 events0 affected7 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected7 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected7 at risk
EG0310 events0 affected3 at risk
Oral mucosal erythema
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected2 at risk
EG0200 events0 affected7 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0250 events0 affected3 at risk
EG0261 events1 affected7 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected7 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected7 at risk
EG0310 events0 affected3 at risk
Oral pain
Gastrointestinal disorders
MedDRA (Unspecified)
Systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected2 at risk
EG0200 events0 affected7 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0250 events0 affected3 at risk
EG0261 events1 affected7 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected7 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected7 at risk
EG0310 events0 affected3 at risk
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA (Unspecified)
Non-systematic Assessment
EG0000 events0 affected2 at risk
EG0010 events0 affected1 at risk
EG0020 events0 affected4 at risk
EG0030 events0 affected2 at risk
EG0040 events0 affected4 at risk
EG0050 events0 affected2 at risk
EG0060 events0 affected4 at risk
EG0070 events0 affected2 at risk
EG0080 events0 affected7 at risk
EG0090 events0 affected3 at risk
EG0100 events0 affected7 at risk
EG0110 events0 affected3 at risk
EG0120 events0 affected7 at risk
EG0130 events0 affected3 at risk
EG0140 events0 affected7 at risk
EG0150 events0 affected3 at risk
EG0160 events0 affected7 at risk
EG0170 events0 affected3 at risk
EG0180 events0 affected4 at risk
EG0190 events0 affected2 at risk
EG0200 events0 affected7 at risk
EG0210 events0 affected3 at risk
EG0220 events0 affected7 at risk
EG0230 events0 affected2 at risk
EG0240 events0 affected6 at risk
EG0250 events0 affected3 at risk
EG0261 events1 affected7 at risk
EG0270 events0 affected3 at risk
EG0280 events0 affected7 at risk
EG0290 events0 affected3 at risk
EG0300 events0 affected7 at risk
EG0310 events0 affected3 at risk
Puffy and wrinkling sensation, bilateral buccal mucosa