Trial Outcomes & Findings for Anti-caries Potential of a Sodium Monofluorophosphate and Calcium Sodium Phosphosilicate Dentifrice (NCT NCT01657877)
NCT ID: NCT01657877
Last Updated: 2014-10-01
Results Overview
Percent SMH recovery (SMHR) was calculated from hardness values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: \[(D1-R)/ (D1-B)\]\*100. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
Baseline to 21 days
Results posted on
2014-10-01
Participant Flow
Participants were recruited at one clinical site (US).
A total of 95 participants were screened, of which 79 were randomized. Of the subjects who were not randomized, 11 did not meet the study criteria; 3 had protocol violations; 2 withdrew consent.
Participant milestones
| Measure |
Overall Participants
In this cross-over study, participant partial dentures were modified to hold two enamel specimens. Denture was modified at the start of the first treatment period to hold the enamel specimens. The participants were randomized using a computer generated program to receive following dentifrices:
1. Dentifrice containing 1500 parts per million (ppm) as sodium monofluorophosphate (SMFP) + 5% calcium sodium phosphosilicate (CSP)
2. Dentifrice containing 1500 ppm fluoride as SMFP + 0% CSP
3. Dentifrice containing 500 ppm fluoride as SMFP + 0% CSP
4. Dentifrice containing 0 ppm fluoride + 0% CSP
5. Dentifrice containing 0 ppm fluoride + 5% CSP. The participants applied the given dentifrice as per their treatment group to a toothbrush and brushed their natural teeth twice daily for one timed minute. There was a washout period of 6 days between each treatment period.
|
|---|---|
|
Overall Study
STARTED
|
79
|
|
Overall Study
Received 500ppm Fluoride as SMFP+ 0% CSP
|
70
|
|
Overall Study
Received 1500ppm Fluoride as SMFP+5% CSP
|
75
|
|
Overall Study
Received 0ppm Fluoride+ 5% CSP
|
71
|
|
Overall Study
Received 0ppm Fluoride+ 0% CSP
|
69
|
|
Overall Study
Received 1500ppm Fluoride as SMFP+0% CSP
|
71
|
|
Overall Study
COMPLETED
|
65
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Overall Participants
In this cross-over study, participant partial dentures were modified to hold two enamel specimens. Denture was modified at the start of the first treatment period to hold the enamel specimens. The participants were randomized using a computer generated program to receive following dentifrices:
1. Dentifrice containing 1500 parts per million (ppm) as sodium monofluorophosphate (SMFP) + 5% calcium sodium phosphosilicate (CSP)
2. Dentifrice containing 1500 ppm fluoride as SMFP + 0% CSP
3. Dentifrice containing 500 ppm fluoride as SMFP + 0% CSP
4. Dentifrice containing 0 ppm fluoride + 0% CSP
5. Dentifrice containing 0 ppm fluoride + 5% CSP. The participants applied the given dentifrice as per their treatment group to a toothbrush and brushed their natural teeth twice daily for one timed minute. There was a washout period of 6 days between each treatment period.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Protocol Violation
|
6
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Other Reason
|
2
|
Baseline Characteristics
Anti-caries Potential of a Sodium Monofluorophosphate and Calcium Sodium Phosphosilicate Dentifrice
Baseline characteristics by cohort
| Measure |
All Randomized Participants
n=79 Participants
All randomized participants were evaluated for baseline characteristics.
|
|---|---|
|
Age, Continuous
|
63.5 Years
STANDARD_DEVIATION 9.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 21 daysPopulation: Per protocol (PP) population: The per protocol (PP) population was defined as those subjects in the intention to treat population who did not have protocol violations leading to exclusion of all efficacy data from analyses. Missing data was not imputed.
Percent SMH recovery (SMHR) was calculated from hardness values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: \[(D1-R)/ (D1-B)\]\*100. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome.
Outcome measures
| Measure |
Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP
n=70 Participants
Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
|
Dentifrice Containing 0 Ppm Fluoride + 0% CSP
n=75 Participants
Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 0 ppm fluoride and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
|
Dentifrice Containing 0 Ppm Fluoride + 5% CSP
Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 0 ppm fluoride and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
|
Dentifrice Containing 0 Ppm Fluoride + 0% CSP
Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and no CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
|
Dentifrice Containing 0 Ppm Fluoride + 5% CSP
Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
|
|---|---|---|---|---|---|
|
Percentage (%) Change in Surface Microhardness (SMH) Following 21 Days of Twice Daily Treatment With the 1500 Ppm Fluoride + 5% CSP Dentifrice and With the 1500 Ppm Fluoride Dentifrice.
|
30.15 Percentage SMHR
Standard Error 2.447
|
32.32 Percentage SMHR
Standard Error 2.673
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 21 daysPopulation: PP population:all randomized participants in the ITT population who had no protocol violations leading to exclusion of all efficacy data from analyses.
Percent SMH recovery (SMHR) was calculated from hardness values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: \[(D1-R)/ (D1-B)\]\*100. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome.
Outcome measures
| Measure |
Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP
n=70 Participants
Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
|
Dentifrice Containing 0 Ppm Fluoride + 0% CSP
n=69 Participants
Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 0 ppm fluoride and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
|
Dentifrice Containing 0 Ppm Fluoride + 5% CSP
n=70 Participants
Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 0 ppm fluoride and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
|
Dentifrice Containing 0 Ppm Fluoride + 0% CSP
Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and no CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
|
Dentifrice Containing 0 Ppm Fluoride + 5% CSP
Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
|
|---|---|---|---|---|---|
|
Percentage (%) Change in SMH Following 21 Days of Twice Daily Treatment With 500 Ppm Fluoride as SMFP and 0 % CSP Dentifrice, 0 Ppm Fluoride and 0% CSP, and 0 Ppm Fluoride and 5 % CSP.
|
18.72 Percentage SMHR
Standard Error 1.649
|
14.74 Percentage SMHR
Standard Error 1.362
|
14.01 Percentage SMHR
Standard Error 1.392
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 21 daysPopulation: PP population: all randomized participants in the ITT population who had no protocol violations leading to exclusion of all efficacy data from analyses. Missing data was not imputed. Due to drop out there were differences in the number of participants analyzed per treatment group.
Change to EFU was determine using a microdrill enamel biopsy of the in situ enamel specimens.
Outcome measures
| Measure |
Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP
n=75 Participants
Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
|
Dentifrice Containing 0 Ppm Fluoride + 0% CSP
n=70 Participants
Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 0 ppm fluoride and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
|
Dentifrice Containing 0 Ppm Fluoride + 5% CSP
n=70 Participants
Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 0 ppm fluoride and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
|
Dentifrice Containing 0 Ppm Fluoride + 0% CSP
n=69 Participants
Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and no CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
|
Dentifrice Containing 0 Ppm Fluoride + 5% CSP
n=70 Participants
Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
|
|---|---|---|---|---|---|
|
Enamel Fluoride Uptake (EFU)
|
15.58 ppm EFU
Standard Error 0.784
|
14.85 ppm EFU
Standard Error 0.729
|
9.23 ppm EFU
Standard Error 0.440
|
4.17 ppm EFU
Standard Error 0.241
|
4.54 ppm EFU
Standard Error 0.291
|
Adverse Events
Dentifrice Containing 1500 Ppm Fluoride as SMFP + 5% CSP
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Dentifrice Containing 1500 Ppm Fluoride as SMFP + 0% CSP
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP
Serious events: 2 serious events
Other events: 14 other events
Deaths: 0 deaths
Dentifrice Containing 0 Ppm Fluoride + 0% CSP
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Dentifrice Containing 0 Ppm Fluoride + 5% CSP
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dentifrice Containing 1500 Ppm Fluoride as SMFP + 5% CSP
n=75 participants at risk
Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
|
Dentifrice Containing 1500 Ppm Fluoride as SMFP + 0% CSP
n=71 participants at risk
Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
|
Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP
n=70 participants at risk
Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
|
Dentifrice Containing 0 Ppm Fluoride + 0% CSP
n=69 participants at risk
Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and no CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
|
Dentifrice Containing 0 Ppm Fluoride + 5% CSP
n=71 participants at risk
Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive lobular carcinoma of left breast
|
1.3%
1/75 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Cardiac disorders
Unstable angina pectoris
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/70 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma of bones
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/70 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
Other adverse events
| Measure |
Dentifrice Containing 1500 Ppm Fluoride as SMFP + 5% CSP
n=75 participants at risk
Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
|
Dentifrice Containing 1500 Ppm Fluoride as SMFP + 0% CSP
n=71 participants at risk
Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
|
Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP
n=70 participants at risk
Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
|
Dentifrice Containing 0 Ppm Fluoride + 0% CSP
n=69 participants at risk
Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and no CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
|
Dentifrice Containing 0 Ppm Fluoride + 5% CSP
n=71 participants at risk
Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gingival ulceration
|
2.7%
2/75 • Number of events 2 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
2.8%
2/71 • Number of events 2 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Nervous system disorders
Headache
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
2.9%
2/69 • Number of events 2 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Nervous system disorders
Amnesia
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Nervous system disorders
Dizziness
|
1.3%
1/75 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar inflammation
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Injury, poisoning and procedural complications
Gingival injury
|
1.3%
1/75 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
2.9%
2/70 • Number of events 2 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/69 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Gastrointestinal disorders
Gingival erythema
|
1.3%
1/75 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
4.3%
3/70 • Number of events 3 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/69 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
5.6%
4/71 • Number of events 4 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/70 • Number of events 3 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/70 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Gastrointestinal disorders
Constipation
|
1.3%
1/75 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Gastrointestinal disorders
Oral mucosal exfoliation
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/69 • Number of events 2 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
General disorders
Dental caries
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/70 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Gastrointestinal disorders
Gingival inflammation
|
1.3%
1/75 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/70 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Gastrointestinal disorders
Glossitis
|
1.3%
1/75 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/70 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Gastrointestinal disorders
Loose tooth
|
1.3%
1/75 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Gastrointestinal disorders
Sensitivity of teeth
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/70 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/69 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Gastrointestinal disorders
Tooth deposit
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/70 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Gastrointestinal disorders
Tooth disorder
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
2.8%
2/71 • Number of events 2 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
2.9%
2/70 • Number of events 2 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/69 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Gastrointestinal disorders
Urinary tract infection
|
1.3%
1/75 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/70 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/71 • Number of events 2 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Infections and infestations
Gastroenteritis viral
|
1.3%
1/75 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/69 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/69 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Infections and infestations
Pneumonia
|
1.3%
1/75 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
1.3%
1/75 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/70 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral fibroma
|
1.3%
1/75 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Surgical and medical procedures
Tooth repair
|
2.7%
2/75 • Number of events 2 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
General disorders
Nodule
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/70 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/69 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/69 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/70 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Eye disorders
Eyelid irritation
|
1.3%
1/75 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/69 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Vascular disorders
Hypertension
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.3%
1/75 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/71 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
2.8%
2/71 • Number of events 2 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.3%
1/75 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/69 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/69 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/75 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/70 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
1.4%
1/69 • Number of events 1 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
0.00%
0/71 • Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.
|
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