Trial Outcomes & Findings for Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride (NCT NCT01563172)
NCT ID: NCT01563172
Last Updated: 2018-02-07
Results Overview
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer \[μm\]) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): \[D1-R/D1-B\] ×100.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
65 participants
Primary outcome timeframe
At Baseline and at Day 14
Results posted on
2018-02-07
Participant Flow
Participants were recruited from 1 center in the USA.
Total of 74 participants were screened for the study, out of which 65 participants were randomized in the study. Nine participants were screen failures.
Participant milestones
| Measure |
Overall
This was a five arm cross-over study. Five arms were divided according to the different treatment regimens, the participants were received all the following treatment regimens during the study: 1. Experimental dentifrice 0.5 grams (g) for 45 seconds, 2. Experimental dentifrice 0.5g for 2 minutes, 3. Experimental dentifrice 1.5g for 45 seconds, 4. Experimental dentifrice 1.5g for 2 minutes, and 5. Control dentifrice 1.5g for 2 minutes only.
|
|---|---|
|
Overall Study
STARTED
|
65
|
|
Overall Study
Experimental Dentifrice 0.5g/2 Min
|
59
|
|
Overall Study
Experimental Dentifrice 0.5g/45 Sec
|
59
|
|
Overall Study
Experimental Dentifrice 1.5g/ 2min
|
58
|
|
Overall Study
Experimental Dentifrice 1.5g/ 45 Sec
|
58
|
|
Overall Study
Control Dentifrice
|
60
|
|
Overall Study
COMPLETED
|
52
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Overall
This was a five arm cross-over study. Five arms were divided according to the different treatment regimens, the participants were received all the following treatment regimens during the study: 1. Experimental dentifrice 0.5 grams (g) for 45 seconds, 2. Experimental dentifrice 0.5g for 2 minutes, 3. Experimental dentifrice 1.5g for 45 seconds, 4. Experimental dentifrice 1.5g for 2 minutes, and 5. Control dentifrice 1.5g for 2 minutes only.
|
|---|---|
|
Overall Study
Adverse Event
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Other (Protocol deviation)
|
5
|
|
Overall Study
Other (Not specified)
|
1
|
Baseline Characteristics
Effect of Dentifrice Usage Regime on Delivery and Efficacy of Fluoride
Baseline characteristics by cohort
| Measure |
Overall
n=65 Participants
This was a five arm cross-over study. Five arms were divided according to the different treatment regimens, the participants were received all the following treatment regimens during the study: 1. Experimental dentifrice 0.5 grams (g) for 45 seconds, 2. Experimental dentifrice 0.5g for 2 minutes, 3. Experimental dentifrice 1.5g for 45 seconds, 4. Experimental dentifrice 1.5g for 2 minutes, and 5. Control dentifrice 1.5g for 2 minutes only.
|
|---|---|
|
Age, Continuous
|
63.6 Years
STANDARD_DEVIATION 8.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
37 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At Baseline and at Day 14Population: Per Protocol (PP) population: Included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (micrometer \[μm\]) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): \[D1-R/D1-B\] ×100.
Outcome measures
| Measure |
Experimental Dentifrice 1.5g, 2 Minutes Brushing Group
n=57 Participants
Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
|
Experimental Dentifrice 1.5g, 45 Seconds Brushing Group
n=53 Participants
Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
|
|---|---|---|
|
Percentage Surface Micro Hardness Recovery (% SMH), of Brushing for 2 Minutes Versus (vs.) Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.
|
41.61 % SMH
Standard Error 2.244
|
34.66 % SMH
Standard Error 2.284
|
SECONDARY outcome
Timeframe: At Baseline and at Day 14Population: PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): \[D1-R/D1-B\] ×100.
Outcome measures
| Measure |
Experimental Dentifrice 1.5g, 2 Minutes Brushing Group
n=58 Participants
Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
|
Experimental Dentifrice 1.5g, 45 Seconds Brushing Group
n=55 Participants
Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
|
|---|---|---|
|
Percentage Surface Micro Hardness (% SMH) Recovery , of Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice.
|
30.75 % SMH
Standard Error 2.232
|
25.05 % SMH
Standard Error 2.266
|
SECONDARY outcome
Timeframe: At Baseline and at Day 14Population: PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): \[D1-R/D1-B\] ×100.
Outcome measures
| Measure |
Experimental Dentifrice 1.5g, 2 Minutes Brushing Group
n=58 Participants
Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
|
Experimental Dentifrice 1.5g, 45 Seconds Brushing Group
n=57 Participants
Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
|
|---|---|---|
|
Percentage Surface Micro Hardness (% SMH) Recovery, of Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice.
|
30.75 % SMH
Standard Error 2.232
|
41.61 % SMH
Standard Error 2.244
|
SECONDARY outcome
Timeframe: At Baseline and at Day 14Population: PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): \[D1-R/D1-B\] ×100.
Outcome measures
| Measure |
Experimental Dentifrice 1.5g, 2 Minutes Brushing Group
n=55 Participants
Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
|
Experimental Dentifrice 1.5g, 45 Seconds Brushing Group
n=53 Participants
Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
|
|---|---|---|
|
Percentage Surface Micro-hardness Recovery (% SMH), of Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.
|
25.05 % SMH
Standard Error 2.266
|
34.66 % SMH
Standard Error 2.284
|
SECONDARY outcome
Timeframe: At Baseline and at Day 14Population: PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH recovery was performed in-vitro and determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents re-hardening of enamel surface. % SMH recovery was calculated from indentation length (μm) of sound enamel specimen at baseline (B), indentation length (μm) after in vitro demineralization (D1), indentation length (μm) after intra-oral exposure (R): \[D1-R/D1-B\] ×100.
Outcome measures
| Measure |
Experimental Dentifrice 1.5g, 2 Minutes Brushing Group
n=57 Participants
Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
|
Experimental Dentifrice 1.5g, 45 Seconds Brushing Group
n=58 Participants
Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
|
|---|---|---|
|
Percent Surface Micro-hardness (% SMH) Recovery, of Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of an Control Dentifrice.
|
41.61 % SMH
Standard Error 2.244
|
26.23 % SMH
Standard Error 2.232
|
SECONDARY outcome
Timeframe: At Day 14Population: PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
Outcome measures
| Measure |
Experimental Dentifrice 1.5g, 2 Minutes Brushing Group
n=57 Participants
Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
|
Experimental Dentifrice 1.5g, 45 Seconds Brushing Group
n=53 Participants
Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
|
|---|---|---|
|
Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.
|
2426.51 micrograms (μg)×F/centimeters(cm)2
Standard Error 103.802
|
1912.51 micrograms (μg)×F/centimeters(cm)2
Standard Error 106.620
|
SECONDARY outcome
Timeframe: At Day 14Population: PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
Outcome measures
| Measure |
Experimental Dentifrice 1.5g, 2 Minutes Brushing Group
n=58 Participants
Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
|
Experimental Dentifrice 1.5g, 45 Seconds Brushing Group
n=55 Participants
Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
|
|---|---|---|
|
Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes vs. Brushing for 45 Seconds With 0.5g of Experimental Dentifrice.
|
1603.63 μg×F/cm2
Standard Error 103.018
|
1337.72 μg×F/cm2
Standard Error 105.260
|
SECONDARY outcome
Timeframe: At Day 14Population: PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
Outcome measures
| Measure |
Experimental Dentifrice 1.5g, 2 Minutes Brushing Group
n=58 Participants
Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
|
Experimental Dentifrice 1.5g, 45 Seconds Brushing Group
n=57 Participants
Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
|
|---|---|---|
|
Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 0.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Experimental Dentifrice.
|
1603.63 μg×F/cm2
Standard Error 103.018
|
2426.51 μg×F/cm2
Standard Error 103.802
|
SECONDARY outcome
Timeframe: At Day 14Population: PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
Outcome measures
| Measure |
Experimental Dentifrice 1.5g, 2 Minutes Brushing Group
n=55 Participants
Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
|
Experimental Dentifrice 1.5g, 45 Seconds Brushing Group
n=53 Participants
Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
|
|---|---|---|
|
Enamel Fluoride Uptake (EFU) After Brushing for 45 Seconds With 0.5g of Experimental Dentifrice vs. Brushing for 45 Seconds With 1.5g of Experimental Dentifrice.
|
1337.72 μg×F/cm2
Standard Error 105.260
|
1912.51 μg×F/cm2
Standard Error 106.620
|
SECONDARY outcome
Timeframe: At Day 14Population: PP population included all randomized participants who had no major protocol deviations that were felt by the investigator to have affected the assessment of efficacy for all treatments.
EFU was measured by using micro-drill analysis of the enamel specimens carried out after 14 days of intra-oral exposure for each of the toothpaste treatments. The amount of fluoride-uptake by enamel was calculated based on the amount of fluoride divided by the area of the enamel cores.
Outcome measures
| Measure |
Experimental Dentifrice 1.5g, 2 Minutes Brushing Group
n=57 Participants
Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
|
Experimental Dentifrice 1.5g, 45 Seconds Brushing Group
n=58 Participants
Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
|
|---|---|---|
|
Enamel Fluoride Uptake (EFU) After Brushing for 2 Minutes With 1.5g of Experimental Dentifrice vs. Brushing for 2 Minutes With 1.5g of Control Dentifrice.
|
2426.51 μg×F/cm2
Standard Error 103.802
|
1132.18 μg×F/cm2
Standard Error 103.044
|
Adverse Events
Experimental Dentifrice 0.5g, 45 Seconds Brushing Group
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Experimental Dentifrice 0.5g, 2 Minutes Brushing Group
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Experimental Dentifrice 1.5g, 45 Seconds Brushing Group
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Experimental Dentifrice 1.5g, 2 Minutes Brushing Group
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Contol Group
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental Dentifrice 0.5g, 45 Seconds Brushing Group
n=59 participants at risk
Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 0.5g dose of experimental dentifrice.
|
Experimental Dentifrice 0.5g, 2 Minutes Brushing Group
n=59 participants at risk
Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 0.5g dose of experimental dentifrice.
|
Experimental Dentifrice 1.5g, 45 Seconds Brushing Group
n=58 participants at risk
Participants in this arm brushed their teeth twice a daily (morning and evening) for 45 seconds with 1.5g dose of experimental dentifrice.
|
Experimental Dentifrice 1.5g, 2 Minutes Brushing Group
n=58 participants at risk
Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with 1.5g dose of experimental dentifrice.
|
Contol Group
n=60 participants at risk
Participants in this arm brushed their teeth twice a daily (morning and evening) for 2 minutes with control dentifrice.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gingival mucosa imprint from teeth 28 and 29
|
1.7%
1/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
General disorders
Common cold
|
5.1%
3/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
3.4%
2/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
5.2%
3/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
3.4%
2/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
General disorders
Cellulitis lower right leg
|
1.7%
1/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat left side
|
1.7%
1/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
General disorders
Sprained right ankle
|
1.7%
1/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
General disorders
Sinus infection
|
1.7%
1/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
General disorders
Kidneys infection
|
1.7%
1/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
Gastrointestinal disorders
Erythema anterior hard palate
|
1.7%
1/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
General disorders
Gout
|
1.7%
1/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
Gastrointestinal disorders
Gingival mucosa edentulous maxillary anterior ridge erythema
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
Gastrointestinal disorders
Swelling of right inside of mouth & lip caused by biting
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
General disorders
Felt very tired
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
Gastrointestinal disorders
Ulceration on gingival lingual 26 ~2mm (millimeter)
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
Gastrointestinal disorders
Gingival mucosa cervical lingual area swollen with exudate
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
General disorders
Back pain from arthritis
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
General disorders
Gout flare-up
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
Gastrointestinal disorders
Gingival mucosa erythema of right posterior edentulous ridge
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
Gastrointestinal disorders
Gingival mucosa erythema left posterior edentulous ridge
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
General disorders
Urinary tract infection
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
General disorders
Boil on vaginal area
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
Gastrointestinal disorders
White coating on tongue
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
General disorders
Chest pains
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
General disorders
Worsening of acid reflux
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
General disorders
Mycosis fungoides of the skin
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
Gastrointestinal disorders
Sore area on ridge area #22 from partial
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
Gastrointestinal disorders
Submandibular area small ulcer not painful
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
General disorders
Seasonal allergies
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
General disorders
Lower back pain
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
General disorders
Diverticulitis
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
General disorders
Sinus drainage
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
General disorders
Erythema facial
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
General disorders
Brown coating on tongue
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
Gastrointestinal disorders
Gingival mucosa erythema lingual tooth 23
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
General disorders
Dizziness and vomiting
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
General disorders
Broke right hip (right intertrochanteric hip fracture)
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
General disorders
Worsening of arthritis
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
Injury, poisoning and procedural complications
Thermal burn anterior hard palate
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
Infections and infestations
Infected tooth 10
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
General disorders
Left eye swollen and red beneath eye
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
General disorders
Stomach virus
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
Gastrointestinal disorders
Labial mucosa chapped lips upper & lower
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
Injury, poisoning and procedural complications
Crown come off tooth 9
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
|
General disorders
Right shoulder pain
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/59 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
0.00%
0/58 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
1.7%
1/60 • Approximately 16 Weeks
All non-oral Adverse events (AEs) were not coded, therefore all the non-oral AEs were reported under system order class (SOC) General disorder.
|
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