Trial Outcomes & Findings for Benzocaine Gel Toothache Dose-Response Study (NCT NCT00474175)
NCT ID: NCT00474175
Last Updated: 2013-02-28
Results Overview
Responder was defined as participant experiencing improvement in pain intensity, as exhibited by a pain score reduction on the Dental Pain Scale (DPS) from baseline of at least 1 unit for two consecutive assessments anytime between the 5 and 20-minute time points. Response in DPS scale was assigned values as 0 (None), 1 (Mild), 2 (Moderate) and 3 (Severe).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
577 participants
Primary outcome timeframe
Baseline, 5, 10, 15 and 20 minutes
Results posted on
2013-02-28
Participant Flow
Participant milestones
| Measure |
Placebo
Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
|
Benzocaine 10%
Single dose of 10% benzocaine gel administered as per product label directions.
|
Benzocaine 20%
Single dose of 20% benzocaine gel administered as per product label directions.
|
|---|---|---|---|
|
Overall Study
STARTED
|
115
|
233
|
229
|
|
Overall Study
Treated
|
115
|
233
|
228
|
|
Overall Study
COMPLETED
|
114
|
226
|
225
|
|
Overall Study
NOT COMPLETED
|
1
|
7
|
4
|
Reasons for withdrawal
| Measure |
Placebo
Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
|
Benzocaine 10%
Single dose of 10% benzocaine gel administered as per product label directions.
|
Benzocaine 20%
Single dose of 20% benzocaine gel administered as per product label directions.
|
|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
|
Overall Study
Ineligible
|
1
|
3
|
1
|
|
Overall Study
Protocol Violation
|
0
|
2
|
1
|
|
Overall Study
Administrative
|
0
|
1
|
0
|
Baseline Characteristics
Benzocaine Gel Toothache Dose-Response Study
Baseline characteristics by cohort
| Measure |
Placebo
n=115 Participants
Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
|
Benzocaine 10%
n=233 Participants
Single dose of 10% benzocaine gel administered as per product label directions.
|
Benzocaine 20%
n=228 Participants
Single dose of 20% benzocaine gel administered as per product label directions.
|
Total
n=576 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age Continuous
|
31.2 Years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
30.8 Years
STANDARD_DEVIATION 12.7 • n=7 Participants
|
31.3 Years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
31.1 Years
STANDARD_DEVIATION 12.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
300 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
276 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, 5, 10, 15 and 20 minutesPopulation: Intent to treat (ITT) population included all randomized participants who received study medication.
Responder was defined as participant experiencing improvement in pain intensity, as exhibited by a pain score reduction on the Dental Pain Scale (DPS) from baseline of at least 1 unit for two consecutive assessments anytime between the 5 and 20-minute time points. Response in DPS scale was assigned values as 0 (None), 1 (Mild), 2 (Moderate) and 3 (Severe).
Outcome measures
| Measure |
Placebo
n=115 Participants
Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
|
Benzocaine 10%
n=233 Participants
Single dose of 10% benzocaine gel administered as per product label directions.
|
Benzocaine 20%
n=228 Participants
Single dose of 20% benzocaine gel administered as per product label directions.
|
|---|---|---|---|
|
Percentage of Participants With a Response
|
70.4 Percentage of participants
|
80.7 Percentage of participants
|
87.3 Percentage of participants
|
SECONDARY outcome
Timeframe: 0 to 120 minutesPopulation: ITT population included all randomized participants who received study medication.
Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief. Stopwatch was active up to 120 minutes after dosing or until stopped by the participant, or rescue medication was administered.
Outcome measures
| Measure |
Placebo
n=115 Participants
Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
|
Benzocaine 10%
n=233 Participants
Single dose of 10% benzocaine gel administered as per product label directions.
|
Benzocaine 20%
n=228 Participants
Single dose of 20% benzocaine gel administered as per product label directions.
|
|---|---|---|---|
|
Time to First Confirmed Perceptible Relief
|
2.0 Minutes
Interval 1.6 to 3.3
|
1.4 Minutes
Interval 1.2 to 1.7
|
1.1 Minutes
Interval 1.0 to 1.3
|
SECONDARY outcome
Timeframe: 0 to 120 minutesPopulation: ITT population included all randomized participants who received study medication.
Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 120 minutes after dosing or until stopped by the participant, or rescue medication was administered.
Outcome measures
| Measure |
Placebo
n=115 Participants
Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
|
Benzocaine 10%
n=233 Participants
Single dose of 10% benzocaine gel administered as per product label directions.
|
Benzocaine 20%
n=228 Participants
Single dose of 20% benzocaine gel administered as per product label directions.
|
|---|---|---|---|
|
Time to Meaningful Relief
|
8.5 Minutes
Interval 5.1 to 15.4
|
4.4 Minutes
Interval 3.7 to 5.8
|
3.2 Minutes
Interval 2.8 to 4.2
|
SECONDARY outcome
Timeframe: 0 to 120 minutesPopulation: ITT population included all randomized participants who received study medication.
Duration of effect was defined as the time difference between onset of effect and its offset. Onset of effect was the first time point at which two consecutive pain scores less severe than at baseline by at least 1 unit (on the DPS) were attained. Offset of effect was the first of the following events to occur after onset: time to drop out if the drop out was due to lack of efficacy, time of rescue medication, or the first time point following onset of effect at which two consecutive pain scores that are at least as severe as at baseline were attained.
Outcome measures
| Measure |
Placebo
n=115 Participants
Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
|
Benzocaine 10%
n=233 Participants
Single dose of 10% benzocaine gel administered as per product label directions.
|
Benzocaine 20%
n=228 Participants
Single dose of 20% benzocaine gel administered as per product label directions.
|
|---|---|---|---|
|
Duration of Effect
|
NA Minutes
Data was not summarized as median time to duration of effect was greater than (\>) 115 minutes for all treatment groups and therefore 95% C.I. was not estimable.
|
NA Minutes
Data was not summarized as median time to duration of effect was \>115 minutes for all treatment groups and therefore 95% C.I. was not estimable.
|
NA Minutes
Data was not summarized as median time to duration of effect was \>115 minutes for all treatment groups and therefore 95% C.I. was not estimable.
|
SECONDARY outcome
Timeframe: 60 minutes and 120 minutesPopulation: ITT population included all randomized participants who received study medication.
SPRID is time-weighted sum of pain relief scores combined with pain intensity difference (PRID) scores over 60 and 120 minutes. SPRID score range was 0 (worst) to 7 (best) for SPRID 60 and 0 (worst) to 14 (best) for SPRID 120. PRID is sum of Pain intensity differences (PID) and Dental pain relief scale (DPRS) scores at each post-dosing time point. PID was calculated as baseline DPS minus DPS score at given time point (DPS range: 0 \[none\] to 3 \[severe\]; baseline DPS range from 2-3). PID score ranges from -1 (worst) to 3 (best). DPRS is 5-point scale ranging from 0 (No-relief) to 4 (Complete).
Outcome measures
| Measure |
Placebo
n=115 Participants
Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
|
Benzocaine 10%
n=233 Participants
Single dose of 10% benzocaine gel administered as per product label directions.
|
Benzocaine 20%
n=228 Participants
Single dose of 20% benzocaine gel administered as per product label directions.
|
|---|---|---|---|
|
Sum of Pain Relief Combined With Pain Intensity Differences (SPRID) Scores
SPRID 60
|
3.1 Units on a scale
Standard Deviation 2.3
|
3.4 Units on a scale
Standard Deviation 2.0
|
3.6 Units on a scale
Standard Deviation 2.0
|
|
Sum of Pain Relief Combined With Pain Intensity Differences (SPRID) Scores
SPRID 120
|
5.9 Units on a scale
Standard Deviation 4.8
|
6.4 Units on a scale
Standard Deviation 4.2
|
6.7 Units on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: 0 to 120 minutesPopulation: ITT population included all randomized participants who received study medication.
Median time of dropping out of the participants from the study due to lack of efficacy or rescue medication (ibuprofen 200-400 mg or acetaminophen 1000 mg), whichever comes first.
Outcome measures
| Measure |
Placebo
n=115 Participants
Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
|
Benzocaine 10%
n=233 Participants
Single dose of 10% benzocaine gel administered as per product label directions.
|
Benzocaine 20%
n=228 Participants
Single dose of 20% benzocaine gel administered as per product label directions.
|
|---|---|---|---|
|
Time to Dropping Out Due to Lack of Efficacy or Rescue Medication
|
NA Minutes
Data was not summarized as median time for dropping out due to lack of efficacy or taking rescue medication for all treatment groups was \>120 minutes (study duration) and therefore 95% C.I. was not estimable.
|
NA Minutes
Data was not summarized as median time for dropping out due to lack of efficacy or taking rescue medication for all treatment groups was \>120 minutes (study duration) and therefore 95% C.I. was not estimable.
|
NA Minutes
Data was not summarized as median time for dropping out due to lack of efficacy or taking rescue medication for all treatment groups was \>120 minutes (study duration) and therefore 95% C.I. was not estimable.
|
SECONDARY outcome
Timeframe: 5 to 120 minutesPopulation: ITT population included all randomized participants who received study medication.
PRID is sum of PID and DPRS scores at each post-dosing time point. The overall possible score range, for PRID is -1 (worst) to 7 (best). PID was calculated as baseline DPS minus DPS score at given time point (DPS range from 0 \[none\] to 3 \[severe\]; baseline DPS range from 2-3). PID score ranges from -1 (worst) to 3 (best). DPRS is 5-point scale ranging from 0 (No-relief) to 4 (Complete).
Outcome measures
| Measure |
Placebo
n=115 Participants
Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
|
Benzocaine 10%
n=233 Participants
Single dose of 10% benzocaine gel administered as per product label directions.
|
Benzocaine 20%
n=228 Participants
Single dose of 20% benzocaine gel administered as per product label directions.
|
|---|---|---|---|
|
Pain Relief Combined With Pain Intensity Difference (PRID) Scores
25 minutes
|
3.12 Units on a scale
Standard Deviation 2.53
|
3.60 Units on a scale
Standard Deviation 2.25
|
3.73 Units on a scale
Standard Deviation 2.27
|
|
Pain Relief Combined With Pain Intensity Difference (PRID) Scores
30 minutes
|
3.11 Units on a scale
Standard Deviation 2.65
|
3.39 Units on a scale
Standard Deviation 2.32
|
3.66 Units on a scale
Standard Deviation 2.38
|
|
Pain Relief Combined With Pain Intensity Difference (PRID) Scores
50 minutes
|
3.20 Units on a scale
Standard Deviation 2.68
|
3.41 Units on a scale
Standard Deviation 2.40
|
3.42 Units on a scale
Standard Deviation 2.45
|
|
Pain Relief Combined With Pain Intensity Difference (PRID) Scores
60 minutes
|
3.17 Units on a scale
Standard Deviation 2.74
|
3.18 Units on a scale
Standard Deviation 2.47
|
3.38 Units on a scale
Standard Deviation 2.57
|
|
Pain Relief Combined With Pain Intensity Difference (PRID) Scores
120 minutes
|
2.73 Units on a scale
Standard Deviation 2.72
|
2.82 Units on a scale
Standard Deviation 2.61
|
2.84 Units on a scale
Standard Deviation 2.56
|
|
Pain Relief Combined With Pain Intensity Difference (PRID) Scores
5 minutes
|
2.72 Units on a scale
Standard Deviation 2.05
|
3.25 Units on a scale
Standard Deviation 1.98
|
3.66 Units on a scale
Standard Deviation 1.87
|
|
Pain Relief Combined With Pain Intensity Difference (PRID) Scores
10 minutes
|
3.08 Units on a scale
Standard Deviation 2.25
|
3.56 Units on a scale
Standard Deviation 2.00
|
3.88 Units on a scale
Standard Deviation 1.97
|
|
Pain Relief Combined With Pain Intensity Difference (PRID) Scores
15 minutes
|
3.18 Units on a scale
Standard Deviation 2.46
|
3.64 Units on a scale
Standard Deviation 2.23
|
3.96 Units on a scale
Standard Deviation 2.07
|
|
Pain Relief Combined With Pain Intensity Difference (PRID) Scores
20 minutes
|
3.21 Units on a scale
Standard Deviation 2.50
|
3.64 Units on a scale
Standard Deviation 2.27
|
3.74 Units on a scale
Standard Deviation 2.23
|
|
Pain Relief Combined With Pain Intensity Difference (PRID) Scores
40 minutes
|
3.06 Units on a scale
Standard Deviation 2.60
|
3.44 Units on a scale
Standard Deviation 2.39
|
3.52 Units on a scale
Standard Deviation 2.43
|
|
Pain Relief Combined With Pain Intensity Difference (PRID) Scores
70 minutes
|
2.98 Units on a scale
Standard Deviation 2.75
|
3.16 Units on a scale
Standard Deviation 2.49
|
3.33 Units on a scale
Standard Deviation 2.59
|
|
Pain Relief Combined With Pain Intensity Difference (PRID) Scores
80 minutes
|
2.91 Units on a scale
Standard Deviation 2.77
|
3.09 Units on a scale
Standard Deviation 2.55
|
3.24 Units on a scale
Standard Deviation 2.60
|
|
Pain Relief Combined With Pain Intensity Difference (PRID) Scores
90 minutes
|
2.78 Units on a scale
Standard Deviation 2.70
|
3.05 Units on a scale
Standard Deviation 2.63
|
3.09 Units on a scale
Standard Deviation 2.61
|
|
Pain Relief Combined With Pain Intensity Difference (PRID) Scores
100 minutes
|
2.78 Units on a scale
Standard Deviation 2.70
|
3.00 Units on a scale
Standard Deviation 2.62
|
2.93 Units on a scale
Standard Deviation 2.58
|
|
Pain Relief Combined With Pain Intensity Difference (PRID) Scores
110 minutes
|
2.70 Units on a scale
Standard Deviation 2.71
|
2.90 Units on a scale
Standard Deviation 2.60
|
2.96 Units on a scale
Standard Deviation 2.59
|
SECONDARY outcome
Timeframe: 120 minutesPopulation: ITT population included all randomized participants who received study medication.
Participants were asked to provide an overall assessment of their satisfaction with the study medication on a categorical scale. Response in this scale was assigned values as 0 (Poor), 1 (Fair), 2 (Good), 3 (Very Good) and 4 (Excellent).
Outcome measures
| Measure |
Placebo
n=115 Participants
Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
|
Benzocaine 10%
n=233 Participants
Single dose of 10% benzocaine gel administered as per product label directions.
|
Benzocaine 20%
n=228 Participants
Single dose of 20% benzocaine gel administered as per product label directions.
|
|---|---|---|---|
|
Global Satisfaction Assessment
|
2.1 Units on a scale
Standard Deviation 1.6
|
2.5 Units on a scale
Standard Deviation 1.2
|
2.5 Units on a scale
Standard Deviation 1.2
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 5 minutesPopulation: Safety population included all participants who received at least 1 dose of study medication and had follow up data.
Amount of study medication applied was calculated by weighing medication tube prior and post-dosing.
Outcome measures
| Measure |
Placebo
n=115 Participants
Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
|
Benzocaine 10%
n=233 Participants
Single dose of 10% benzocaine gel administered as per product label directions.
|
Benzocaine 20%
n=228 Participants
Single dose of 20% benzocaine gel administered as per product label directions.
|
|---|---|---|---|
|
Dosing Compliance Calculated by Evaluating Amount of Study Medication Applied
|
258.6 Milligram (mg)
Standard Deviation 163.4
|
226.8 Milligram (mg)
Standard Deviation 138.2
|
233.1 Milligram (mg)
Standard Deviation 150.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 5 minutesPopulation: Safety population included all participants who received at least 1 dose of study medication and had follow up data.
Outcome measures
| Measure |
Placebo
n=115 Participants
Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
|
Benzocaine 10%
n=233 Participants
Single dose of 10% benzocaine gel administered as per product label directions.
|
Benzocaine 20%
n=228 Participants
Single dose of 20% benzocaine gel administered as per product label directions.
|
|---|---|---|---|
|
Dosing Compliance Calculated by Evaluating Percentage of Participants Who Applied no More Than 400 mg of the Study Medication
|
83.5 Percentage of participants
Interval 75.6 to 89.2
|
89.3 Percentage of participants
Interval 84.6 to 92.6
|
89.5 Percentage of participants
Interval 84.8 to 92.8
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Benzocaine 10%
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Benzocaine 20%
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=115 participants at risk
Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
|
Benzocaine 10%
n=233 participants at risk
Single dose of 10% benzocaine gel administered as per product label directions.
|
Benzocaine 20%
n=228 participants at risk
Single dose of 20% benzocaine gel administered as per product label directions.
|
|---|---|---|---|
|
Eye disorders
Diplopia
|
0.00%
0/115
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.43%
1/233
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/228
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/115
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/233
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.44%
1/228
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Stomach upset
|
0.00%
0/115
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/233
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.44%
1/228
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Toothache
|
0.87%
1/115
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/233
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/228
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Post operation wound infection
|
0.87%
1/115
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/233
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/228
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tooth caries Not Otherwise Specified (NOS)
|
0.00%
0/115
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.43%
1/233
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/228
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood pressure increased
|
0.00%
0/115
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.86%
2/233
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.44%
1/228
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Somnolence
|
0.87%
1/115
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.43%
1/233
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.44%
1/228
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/115
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/233
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.44%
1/228
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/115
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/233
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.44%
1/228
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.87%
1/115
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/233
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/228
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/115
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.43%
1/233
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
0.00%
0/228
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Wyeth has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER