Trial Outcomes & Findings for An Efficacy Study of Chlorhexidine Mouthwashes (NCT NCT01751178)
NCT ID: NCT01751178
Last Updated: 2014-07-28
Results Overview
Measure of gingival severity averaged across whole mouth site; each site scored 0, 1, 2, 3 based on GI and, 1. GSI = 0 if GI is 0 or 1 (no bleeding) 2. GSI = 1 if GI is 1 or 2 (bleeding)
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
324 participants
Primary outcome timeframe
Change from baseline to 6 weeks
Results posted on
2014-07-28
Participant Flow
Participants were recruited at the clinical site.
A total of 775 subjects were screened and 324 subjects were randomised of whom 319 completed the study. The high screen failure rate was due mainly to subjects not having sufficient permanently gradable teeth.
Participant milestones
| Measure |
Mouthwash With Alcohol
Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
|
Mouthwash Without Alcohol
Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
|
Reference
Brushing alone with the standard toothpaste for one timed minute twice daily for 6 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
108
|
109
|
107
|
|
Overall Study
COMPLETED
|
105
|
109
|
105
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
2
|
Reasons for withdrawal
| Measure |
Mouthwash With Alcohol
Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
|
Mouthwash Without Alcohol
Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
|
Reference
Brushing alone with the standard toothpaste for one timed minute twice daily for 6 weeks.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
0
|
|
Overall Study
Other Reason (unknown)
|
1
|
0
|
2
|
Baseline Characteristics
An Efficacy Study of Chlorhexidine Mouthwashes
Baseline characteristics by cohort
| Measure |
Mouthwash With Alcohol
n=108 Participants
Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
|
Mouthwash Without Alcohol
n=109 Participants
Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
|
Reference
n=107 Participants
Brushing alone with the standard toothpaste for 1 timed minute twice daily for 6 weeks.
|
Total
n=324 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.8 Years
STANDARD_DEVIATION 10.89 • n=5 Participants
|
36.2 Years
STANDARD_DEVIATION 11.31 • n=7 Participants
|
36.5 Years
STANDARD_DEVIATION 10.48 • n=5 Participants
|
36.8 Years
STANDARD_DEVIATION 10.89 • n=4 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
239 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
85 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 6 weeksPopulation: This analysis was conducted on the Intent-to-Treat (ITT) population, defined as those subjects who received study treatment and had at least one post-baseline efficacy measurement.
Measure of gingival severity averaged across whole mouth site; each site scored 0, 1, 2, 3 based on GI and, 1. GSI = 0 if GI is 0 or 1 (no bleeding) 2. GSI = 1 if GI is 1 or 2 (bleeding)
Outcome measures
| Measure |
Mouthwash With Alcohol
n=105 Participants
Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
|
Mouthwash Without Alcohol
n=109 Participants
Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
|
Reference
n=105 Participants
Brushing alone with the standard toothpaste for 1 timed minute twice daily for 6 weeks.
|
|---|---|---|---|
|
Gingival Severity Index (GSI) Based on the Gingival Index (GI)
|
0.152 Units on a scale
Standard Error 0.0085
|
0.143 Units on a scale
Standard Error 0.0072
|
0.212 Units on a scale
Standard Error 0.0121
|
SECONDARY outcome
Timeframe: Change from baseline to 6 weeksPopulation: This analysis was conducted on the Intent-to-Treat (ITT) population, defined as those subjects who received study treatment and had at least one post-baseline efficacy measurement.
The GI was assessed on the facial and lingual surfaces at six sites on each tooth (facial and lingual - distal papillae, margin and mesial papillae). These assessments were performed on all evaluable teeth using moderate pressure sweeping a blunt ended probe, which was engaged in approximately 1 millimetre (mm) into the gingival crevice. The scores could range from 0-3 (0=Absence of inflammation; 1=Mild Inflammation-Slight change in color slight change in texture, no bleeding on probing; 2=Moderate Inflammation -glazing, redness edema and hypertrophy, bleeding on probing; 3= Severe inflammation-marked redness and hypertrophy, tendency for spontaneous bleeding)
Outcome measures
| Measure |
Mouthwash With Alcohol
n=105 Participants
Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
|
Mouthwash Without Alcohol
n=109 Participants
Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
|
Reference
n=105 Participants
Brushing alone with the standard toothpaste for 1 timed minute twice daily for 6 weeks.
|
|---|---|---|---|
|
Gingival Index
|
1.12 Units on a scale
Standard Error 0.012
|
1.11 Units on a scale
Standard Error 0.010
|
1.19 Units on a scale
Standard Error 0.014
|
SECONDARY outcome
Timeframe: Change from baseline to 6 weeksPopulation: This analysis was conducted on the Intent-to-Treat (ITT) population, defined as those subjects who received study treatment and had at least one post-baseline efficacy measurement.
Overall plaque scores were calculated taking the average over all tooth sites for a participant. The scores could range from 0-5 (0=No plaque; 1=Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3=A band of plaque wider than 1 mm but covering less than 1/3 of the area to be graded of the crown of the tooth; 4=Plaque covering at least 1/3 but less than 2/3 of the area to be graded of the crown of the tooth; 5=Plaque covering 2/3 or more of the area to be graded of the crown of the tooth)
Outcome measures
| Measure |
Mouthwash With Alcohol
n=105 Participants
Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
|
Mouthwash Without Alcohol
n=109 Participants
Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
|
Reference
n=105 Participants
Brushing alone with the standard toothpaste for 1 timed minute twice daily for 6 weeks.
|
|---|---|---|---|
|
Turesky Modification of Quigley & Hein Plaque Index for Overall Plaque Scores
|
2.50 Units on a scale
Standard Error 0.082
|
2.40 Units on a scale
Standard Error 0.084
|
3.34 Units on a scale
Standard Error 0.062
|
SECONDARY outcome
Timeframe: Change from baseline to 6 weeksPopulation: This analysis was conducted on ITT population, defined as those subjects who received study treatment and had at least one post-baseline efficacy measurement.
Interproximal plaque scores were analyzed on the mesiofacial, distofacial, mesiolingual and distolingual surfaces, and calculated taking the average over all tooth sites for a participant. The scores could range from 0-5 (0=No plaque; 1=Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3=A band of plaque wider than 1 mm but covering less than 1/3 of the area to be graded of the crown of the tooth; 4=Plaque covering at least 1/3 but less than 2/3 of the area to be graded of the crown of the tooth; 5=Plaque covering 2/3 or more of the area to be graded of the crown of the tooth)
Outcome measures
| Measure |
Mouthwash With Alcohol
n=105 Participants
Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
|
Mouthwash Without Alcohol
n=109 Participants
Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
|
Reference
n=105 Participants
Brushing alone with the standard toothpaste for 1 timed minute twice daily for 6 weeks.
|
|---|---|---|---|
|
Turesky Modification of Quigley & Hein Plaque Index for Interproximal Plaque Scores
|
2.77 Units on a scale
Standard Error 0.090
|
2.63 Units on a scale
Standard Error 0.091
|
3.69 Units on a scale
Standard Error 0.065
|
Adverse Events
Mouthwash With Alcohol
Serious events: 0 serious events
Other events: 67 other events
Deaths: 0 deaths
Mouthwash Without Alcohol
Serious events: 1 serious events
Other events: 60 other events
Deaths: 0 deaths
Reference
Serious events: 0 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mouthwash With Alcohol
n=108 participants at risk
Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
|
Mouthwash Without Alcohol
n=109 participants at risk
Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
|
Reference
n=107 participants at risk
Brushing alone with the standard toothpaste for one timed minute twice daily for 6 weeks.
|
|---|---|---|---|
|
Infections and infestations
Cellulitis left thigh
|
0.00%
0/108 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.92%
1/109 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
Other adverse events
| Measure |
Mouthwash With Alcohol
n=108 participants at risk
Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
|
Mouthwash Without Alcohol
n=109 participants at risk
Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
|
Reference
n=107 participants at risk
Brushing alone with the standard toothpaste for one timed minute twice daily for 6 weeks.
|
|---|---|---|---|
|
Gastrointestinal disorders
Tongue coated
|
12.0%
13/108 • Number of events 13 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
7.3%
8/109 • Number of events 8 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
1.9%
2/107 • Number of events 2 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Gastrointestinal disorders
Glossodynia
|
4.6%
5/108 • Number of events 5 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
8.3%
9/109 • Number of events 9 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
4.6%
5/108 • Number of events 6 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
5.5%
6/109 • Number of events 6 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Nervous system disorders
Headache
|
17.6%
19/108 • Number of events 32 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
12.8%
14/109 • Number of events 30 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
12.1%
13/107 • Number of events 19 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Nervous system disorders
Ageusia
|
2.8%
3/108 • Number of events 3 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
5.5%
6/109 • Number of events 7 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.2%
11/108 • Number of events 11 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
8.3%
9/109 • Number of events 9 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
8.4%
9/107 • Number of events 9 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Nervous system disorders
Dysgeusia
|
5.6%
6/108 • Number of events 6 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.92%
1/109 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Gastrointestinal disorders
Mouth ulceration
|
2.8%
3/108 • Number of events 5 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
1.8%
2/109 • Number of events 2 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
2.8%
3/107 • Number of events 3 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Gastrointestinal disorders
Dry mouth
|
3.7%
4/108 • Number of events 4 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
4.6%
5/109 • Number of events 5 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
1.9%
2/108 • Number of events 2 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
4.6%
5/109 • Number of events 6 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Infections and infestations
Oral herpes
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
1.8%
2/109 • Number of events 2 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
4.7%
5/107 • Number of events 5 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Injury, poisoning and procedural complications
Mouth injury
|
3.7%
4/108 • Number of events 4 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.92%
1/109 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
1.9%
2/107 • Number of events 2 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
3.7%
4/109 • Number of events 4 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/108 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.92%
1/109 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.93%
1/107 • Number of events 3 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Gastrointestinal disorders
Oral discomfort
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
2.8%
3/109 • Number of events 3 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Injury, poisoning and procedural complications
Gingival injury
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
1.8%
2/109 • Number of events 2 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Gastrointestinal disorders
Lip ulceration
|
1.9%
2/108 • Number of events 2 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Infections and infestations
Tonsillitis
|
1.9%
2/108 • Number of events 2 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/108 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
1.8%
2/109 • Number of events 2 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/108 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
1.9%
2/107 • Number of events 2 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Gastrointestinal disorders
Oral mucosal exfoliation
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.92%
1/109 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.92%
1/109 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Gastrointestinal disorders
Tongue disorder
|
1.9%
2/108 • Number of events 2 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.92%
1/109 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
1.9%
2/108 • Number of events 2 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Injury, poisoning and procedural complications
Traumatic ulcer
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.92%
1/109 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Gastrointestinal disorders
Chapped lips
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/108 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Gastrointestinal disorders
Enlarged uvula
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Infections and infestations
Gingival Abscess
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Gastrointestinal disorders
Gingival blister
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Gastrointestinal disorders
Gingival inflammation
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/108 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/108 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Gastrointestinal disorders
Tongue dry
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Infections and infestations
Tongue injury
|
0.00%
0/108 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/108 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/108 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.92%
1/109 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Gastrointestinal disorders
Toothache
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.9%
2/108 • Number of events 2 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
2.8%
3/109 • Number of events 4 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
1.9%
2/107 • Number of events 2 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.93%
1/108 • Number of events 2 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.92%
1/109 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
3.7%
4/107 • Number of events 4 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Gastrointestinal disorders
Vomiting
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
3.7%
4/109 • Number of events 4 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.92%
1/109 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
2.8%
3/107 • Number of events 3 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Reproductive system and breast disorders
Oropharyngeal pain
|
2.8%
3/108 • Number of events 3 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.92%
1/109 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
1.8%
2/109 • Number of events 2 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Infections and infestations
Sinusitis
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.93%
1/107 • Number of events 2 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Nervous system disorders
Migraine
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.92%
1/109 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Ear and labyrinth disorders
Otorrhoea
|
0.93%
1/108 • Number of events 2 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
General disorders
Pyrexia
|
0.00%
0/108 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
1.9%
2/107 • Number of events 2 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/108 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/108 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.92%
1/109 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
General disorders
Chills
|
0.00%
0/108 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.92%
1/109 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Investigations
Colposcopy abnormal
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Psychiatric disorders
Depression
|
0.00%
0/108 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Ear and labyrinth disorders
Ear pain
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Eye disorders
Eczema eyelids
|
0.00%
0/108 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.92%
1/109 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/108 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.92%
1/109 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/108 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/108 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/108 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.92%
1/109 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/108 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.92%
1/109 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
0.00%
0/108 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.92%
1/109 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/108 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.92%
1/109 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/108 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.92%
1/109 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.93%
1/108 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/108 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/109 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.93%
1/107 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/108 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.92%
1/109 • Number of events 1 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
0.00%
0/107 • Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER